Cleared Traditional

K963753 - NASP TRANSPARENT DRESSING (FDA 510(k) Clearance)

K963753 · North American Sterilization & Packaging Co. · General & Plastic Surgery device
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Nov 1996
Decision
72d
Days
-
Risk

K963753 is an FDA 510(k) clearance for the NASP TRANSPARENT DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by North American Sterilization & Packaging Co. (Sparta, US). The FDA issued a Cleared decision on November 29, 1996 after a review of 72 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.

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Submission Details

510(k) Number K963753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1996
Decision Date November 29, 1996
Days to Decision 72 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
42d faster than avg
Panel avg: 114d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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