Cleared Traditional

K933328 - DAMOR CREME

K933328 · Damor America, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1993
Decision
152d
Days
-
Risk

K933328 is an FDA 510(k) clearance for the DAMOR CREME. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Damor America, Inc. (Washington, D.C., US). The FDA issued a Cleared decision on December 7, 1993 after a review of 152 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Damor America, Inc. devices

FDA 510(k) Submission Details - K933328

510(k) Number K933328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1993
Decision Date December 07, 1993
Days to Decision 152 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 115d · This submission: 152d
Pathway characteristics
Predicate-based equivalence.

MGQ Device Classification - Class 0,

Product Code MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class -

Regulatory Peers - MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

All 91
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K933328.
CURAFIL WOUND GEL DRESSING
K943073 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jul 1994
BIOLEX IMPREGNATED WOUND DRESSING
K935096 · C.R. Bard, Inc. · Feb 1994
DUODERM IMPROVED CGF CONTROL GEL FORMULA DRESSING
K932101 · Convatec, A Division of E.R. Squibb & Sons · Dec 1993
SOLOSITE DERMAL WOUND GEL
K932263 · Smith & Nephew United, Inc. · Oct 1993
DERMAGRAN WET DRESSING (ZINC-SALINE)
K913344 · Derma Sciences, Inc. · Jul 1992
DERMAGRAN WET DRESSING
K914746 · Derma Sciences, Inc. · Jun 1992