KAPTON PEEL POUCH— 510(k) K933228

Substantially Equivalent

American Fluoroseal Corp.

FDA 510(k) clearance K933228 for KAPTON PEEL POUCH, Substantially Equivalent on 1994-03-30. Applicant: American Fluoroseal Corp.. Device class: 1.

Clearance details

Applicant: American Fluoroseal Corp.
Product code: Code KJA
Device class: Class 1
Regulation: 21 CFR 864.2240
Advisory panel: Hematology
Date received: 1993-07-02
Decision date: 1994-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Silver Spring, MD, US

Download summary PDF View on FDA.gov ↗

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