Cleared Traditional

JELONET PARAFFIN GAUZE DRESSINGS (K791573) - FDA 510(k) Clearance

K791573 · Acme United Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1979
Decision
25d
Days
-
Risk

K791573 is an FDA 510(k) clearance for the JELONET PARAFFIN GAUZE DRESSINGS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Acme United Corp. (Mchenry, US). The FDA issued a Cleared decision on September 4, 1979 after a review of 25 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 Acme United Corp. devices

Submission Details

510(k) Number K791573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1979
Decision Date September 04, 1979
Days to Decision 25 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 115d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -