IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES

Suture, Nonabsorbable, Synthetic, Polyamide

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 Ifsa Sterile Nlylon Monofil Nonabsor Surg Sutures.

Pre-market Notification Details

Device IDK905286
510k NumberK905286
Device Name:IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES
ClassificationSuture, Nonabsorbable, Synthetic, Polyamide
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 CodeGAR  
CFR Regulation Number878.5020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-11-26
Decision Date1991-02-11

NIH GUDID Devices

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