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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, absorbable, natural
510(k) Number K911354
Device Name STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES
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 Number878.4830
Classification Product Code
GAL  
Date Received03/26/1991
Decision Date 10/25/1991
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
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