SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD

Suture, Absorbable, Synthetic

SURGICAL SPECIALTIES CORP.

The following data is part of a premarket notification filed by Surgical Specialties Corp. with the FDA for Ssc's Pcl Monofilament Sas, Violet, Coated, Model Tbd.

Pre-market Notification Details

Device IDK003015
510k NumberK003015
Device Name:SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD
ClassificationSuture, Absorbable, Synthetic
Applicant SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading,  PA  19606
ContactVikki M Hoffman
CorrespondentVikki M Hoffman
SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading,  PA  19606
Product CodeGAN  
CFR Regulation Number878.4830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-09-27
Decision Date2000-12-15

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