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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, synthetic, polypropylene
510(k) Number K911189
Device Name STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE
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 Number878.5010
Classification Product Code
GAW  
Date Received03/18/1991
Decision Date 04/25/1991
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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