PETERS CARDIONYL(TM) SUTURE

Suture, Nonabsorbable, Synthetic, Polyamide

PROMEDICA PRODUCTS, INC.

The following data is part of a premarket notification filed by Promedica Products, Inc. with the FDA for Peters Cardionyl(tm) Suture.

Pre-market Notification Details

Device IDK913102
510k NumberK913102
Device Name:PETERS CARDIONYL(TM) SUTURE
ClassificationSuture, Nonabsorbable, Synthetic, Polyamide
Applicant PROMEDICA PRODUCTS, INC. 620 NEWPORT CENTER DR., SUITE 575 Newport Beach,  CA  92660
ContactLee Hand
CorrespondentLee Hand
PROMEDICA PRODUCTS, INC. 620 NEWPORT CENTER DR., SUITE 575 Newport Beach,  CA  92660
Product CodeGAR  
CFR Regulation Number878.5020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-12
Decision Date1992-08-03

NIH GUDID Devices

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