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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape And Bandage, Adhesive
510(k) Number K883983
Device Name SANIFIX
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 Number880.5240
Classification Product Code
KGX  
Date Received09/20/1988
Decision Date 12/13/1988
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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