MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE

Suture, Absorbable, Synthetic, Polyglycolic Acid

GRAMSMED LLC

The following data is part of a premarket notification filed by Gramsmed Llc with the FDA for Monograms Synthetic Monofilament Absorbable Suture.

Pre-market Notification Details

Device IDK010672
510k NumberK010672
Device Name:MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE
ClassificationSuture, Absorbable, Synthetic, Polyglycolic Acid
Applicant GRAMSMED LLC 2225 DAKOTA DR. Grafton,  WI  53024
ContactAnthony J Dimercurio
CorrespondentAnthony J Dimercurio
GRAMSMED LLC 2225 DAKOTA DR. Grafton,  WI  53024
Product CodeGAM  
CFR Regulation Number878.4493 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-03-06
Decision Date2001-05-18

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