Cleared Traditional

K840498 - EXU-DRY BURN-TRAUMA DRESSING-VARIOUS

K840498 · Fraass Survival Systems, Inc. · General & Plastic Surgery device
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May 1984
Decision
114d
Days
-
Risk

K840498 is an FDA 510(k) clearance for the EXU-DRY BURN-TRAUMA DRESSING-VARIOUS.

Submitted by Fraass Survival Systems, Inc. (Walker, US). The FDA issued a Cleared decision on May 30, 1984 after a review of 114 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 Fraass Survival Systems, Inc. devices

FDA 510(k) Submission Details - K840498

510(k) Number K840498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1984
Decision Date May 30, 1984
Days to Decision 114 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
1d faster than avg
Panel avg: 115d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -