MONODERM SURGICAL SUTURE

Suture, Absorbable, Synthetic, Polyglycolic Acid

SURGICAL SPECIALTIES CORP.

The following data is part of a premarket notification filed by Surgical Specialties Corp. with the FDA for Monoderm Surgical Suture.

Pre-market Notification Details

Device IDK140227
510k NumberK140227
Device Name:MONODERM SURGICAL SUTURE
ClassificationSuture, Absorbable, Synthetic, Polyglycolic Acid
Applicant SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading,  PA  19606
ContactKirsten Stowell Franco
CorrespondentKirsten Stowell Franco
SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading,  PA  19606
Product CodeGAM  
CFR Regulation Number878.4493 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-01-30
Decision Date2014-02-28
Summary:summary

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