GRAMS POLYPROPYLENE NONABSORBABLE SUTURE

Suture, Nonabsorbable, Synthetic, Polypropylene

GRAMSMED LLC

The following data is part of a premarket notification filed by Gramsmed Llc with the FDA for Grams Polypropylene Nonabsorbable Suture.

Pre-market Notification Details

Device IDK002999
510k NumberK002999
Device Name:GRAMS POLYPROPYLENE NONABSORBABLE SUTURE
ClassificationSuture, Nonabsorbable, Synthetic, Polypropylene
Applicant GRAMSMED LLC 2225 DAKOTA DR. Grafton,  WI  53024
ContactAnthony J Dimercurio
CorrespondentAnthony J Dimercurio
GRAMSMED LLC 2225 DAKOTA DR. Grafton,  WI  53024
Product CodeGAW  
CFR Regulation Number878.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-09-26
Decision Date2000-12-18

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