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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K920367
Device Name ULCUFLEX HYDROCULLOID DRESSING
Applicant
Industrias Palex C/O Dma Med-Chem Corp.
Juan Sebastian Bach 12
08021 Barcelona, Direccion
Postal: Apartado 1940,  ES
Applicant Contact ARCADI PRIETO
Correspondent
Industrias Palex C/O Dma Med-Chem Corp.
Juan Sebastian Bach 12
08021 Barcelona, Direccion
Postal: Apartado 1940,  ES
Correspondent Contact ARCADI PRIETO
Regulation Number880.5090
Classification Product Code
KMF  
Date Received01/28/1992
Decision Date 03/26/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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