Cleared Traditional

K833730 - NON ADHERENT BANDAGE/SHEET

K833730 · American Medical Disposable, Inc. · General & Plastic Surgery device
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Jan 1984
Decision
94d
Days
-
Risk

K833730 is an FDA 510(k) clearance for the NON ADHERENT BANDAGE/SHEET. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by American Medical Disposable, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 27, 1984 after a review of 94 days - within the typical 510(k) review window.

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 American Medical Disposable, Inc. devices

Submission Details

510(k) Number K833730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1983
Decision Date January 27, 1984
Days to Decision 94 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 115d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 221
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K833730.
DUODERM FLEXIBLE HYDROACTIVE DRESSINGS
K841287 · Convatec, A Division of E.R. Squibb & Sons · Aug 1984
HYDRON WOUND DRESSING FAST SEAT KIT
K832699 · National Patent Development Corp. · Apr 1984
STERILE ABSORBENT GAUZE BURN & SOUND
K840745 · Chesebrough-Pond'S U.S.A. Co. · Apr 1984
DECUBITUS CARE ABSORBENT DRESSING
K832407 · American Pharmaseal Div. Ahsc · Jan 1984
BARD ABSORPTION DRESSING
K831710 · C.R. Bard, Inc. · Jan 1984
NON - ADHERENT BANDAGE
K833733 · American Medical Disposable, Inc. · Dec 1983