POLYSYN 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 Polysyn Surgical Suture.

Pre-market Notification Details

Device IDK141625
510k NumberK141625
Device Name:POLYSYN SURGICAL SUTURE
ClassificationSuture, Absorbable, Synthetic, Polyglycolic Acid
Applicant SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading,  PA  19606
ContactPaul Amudala
CorrespondentPaul Amudala
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 Received2014-06-17
Decision Date2014-07-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10848782015815 K141625 000
10848782015402 K141625 000
10848782015457 K141625 000
10848782015471 K141625 000
10848782015488 K141625 000
10848782015587 K141625 000
10848782015600 K141625 000
10848782015617 K141625 000
10848782015679 K141625 000
10848782015693 K141625 000
10848782015709 K141625 000
10848782015747 K141625 000
10848782015778 K141625 000
10848782015792 K141625 000
10848782015808 K141625 000
10848782015372 K141625 000

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