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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
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