Cleared Traditional

DERMASEAL (K960847) - FDA 510(k) Clearance

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

Submission Details

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
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 115d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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