QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM

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 Quill Self-retaining System (srs) Comprised Of Monoderm.

Pre-market Notification Details

Device IDK072028
510k NumberK072028
Device Name:QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM
ClassificationSuture, Absorbable, Synthetic, Polyglycolic Acid
Applicant SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading,  PA  19606
ContactLois Smart
CorrespondentLois Smart
SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading,  PA  19606
Product CodeGAM  
CFR Regulation Number878.4493 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-24
Decision Date2007-08-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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