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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Occlusive
510(k) Number K881936
Device Name OPER-FILM-ADHESIVE MEMBRANE
Applicant
Iberhospitex, S.A.
Avenida De Catalunya, # 4
08185 Llissa De Vall
Barcelona, Spain,  ES
Applicant Contact LOPEZ RODRIGUEZ
Correspondent
Iberhospitex, S.A.
Avenida De Catalunya, # 4
08185 Llissa De Vall
Barcelona, Spain,  ES
Correspondent Contact LOPEZ RODRIGUEZ
Regulation Number878.4020
Classification Product Code
NAD  
Date Received05/09/1988
Decision Date 08/31/1988
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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