Cleared Traditional

K960847 - DERMASEAL

K960847 · Bellingham Medical, Inc. · General & Plastic Surgery device
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Apr 1996
Decision
43d
Days
-
Risk

K960847 is an FDA 510(k) clearance for the DERMASEAL. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Bellingham Medical, Inc. (Mendota Heights, US). The FDA issued a Cleared decision on April 4, 1996 after a review of 43 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bellingham Medical, Inc. devices

FDA 510(k) Submission Details - K960847

510(k) Number K960847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1996
Decision Date April 04, 1996
Days to Decision 43 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 115d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

MGP Device Classification - Class 0,

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

All 57
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K960847.
SPYROFLEX PIGMENTED WOUND DRESSING
K963623 · Polymedica Industries, Inc. · Oct 1996
EPIVIEW
K961319 · Convatec, A Division of E.R. Squibb & Sons · Jul 1996
BIO-DRESSING, STERILE ISLAND DRESSING
K961098 · K. W. Griffen Co. · May 1996
SURESKIN BORDER
K960393 · Euromed A/S · Mar 1996
SURESKIN STANDARD
K960394 · Euromed A/S · Mar 1996
SURESKIN THIN
K960404 · Euromed A/S · Mar 1996