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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
510(k) Number K913185
Device Name STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT
Applicant
INTERNACIONAL FARMACEUTICA, S.A. DE C.V.
C/O MEDICAL DEVICE INSPECTION
55 NORTHERN BOULEVARD, STE 301
GREAT NECK,  NY  11021
Applicant Contact ALAN P SCHWARTZ
Correspondent
INTERNACIONAL FARMACEUTICA, S.A. DE C.V.
C/O MEDICAL DEVICE INSPECTION
55 NORTHERN BOULEVARD, STE 301
GREAT NECK,  NY  11021
Correspondent Contact ALAN P SCHWARTZ
Regulation Number878.4495
Classification Product Code
GAQ  
Date Received07/18/1991
Decision Date 12/04/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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