ULCUFLEX HYDROCULLOID DRESSING— 510(k) K920367

Name: FDA 510(k) clearance K920367
Creator: U.S. Food and Drug Administration
Published: 1992-03-26

Substantially Equivalent

Industrias Palex C/O Dma Med-Chem Corp.

FDA 510(k) clearance K920367 for ULCUFLEX HYDROCULLOID DRESSING, Substantially Equivalent on 1992-03-26. Applicant: Industrias Palex C/O Dma Med-Chem Corp.. Device class: 1.

Clearance details

Applicant: Industrias Palex C/O Dma Med-Chem Corp.
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 1992-01-28
Decision date: 1992-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Postal: Apartado 1940, ES

Download summary PDF View on FDA.gov ↗

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K920740 — EPISENSOR PLUS1994-03-07
K920366 — ULCUFLEX HYDROCOLOID POWDER1992-03-26
K920368 — ULCUFLEX HYDROCOLLOID PASTE1992-03-26
K871628 — PALEX (R) OSTOMY1987-07-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.