STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE

Suture, Nonabsorbable, Synthetic, Polypropylene

INTERNACIONAL FARMACEUTICA, S.A. DE C.V.

The following data is part of a premarket notification filed by Internacional Farmaceutica, S.a. De C.v. with the FDA for Sterile Polypropylene Monfil Nonabsorb Surg Suture.

Pre-market Notification Details

Device IDK911189
510k NumberK911189
Device Name:STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE
ClassificationSuture, Nonabsorbable, Synthetic, Polypropylene
Applicant INTERNACIONAL FARMACEUTICA, S.A. DE C.V. C/O MEDICAL DEVICE INSPECTION 55 NORTHERN BOULEVARD, STE 301 Great Neck,  NY  11021
ContactAlan P Schwartz
CorrespondentAlan P Schwartz
INTERNACIONAL FARMACEUTICA, S.A. DE C.V. C/O MEDICAL DEVICE INSPECTION 55 NORTHERN BOULEVARD, STE 301 Great Neck,  NY  11021
Product CodeGAW  
CFR Regulation Number878.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-18
Decision Date1991-04-25

NIH GUDID Devices

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