SERRALAPG

Suture, Absorbable, Synthetic, Polyglycolic Acid

SERRAL, S.A. DE C.V.

The following data is part of a premarket notification filed by Serral, S.a. De C.v. with the FDA for Serralapg.

Pre-market Notification Details

Device IDK033762
510k NumberK033762
Device Name:SERRALAPG
ClassificationSuture, Absorbable, Synthetic, Polyglycolic Acid
Applicant SERRAL, S.A. DE C.V. 5251-18 JOHN TYLER HWY, SUITE 167 Williamsburg,  VA  23185
ContactScott Henderson
CorrespondentScott Henderson
SERRAL, S.A. DE C.V. 5251-18 JOHN TYLER HWY, SUITE 167 Williamsburg,  VA  23185
Product CodeGAM  
CFR Regulation Number878.4493 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-12-02
Decision Date2004-03-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10381780363927 K033762 000
10381780363910 K033762 000
10381780363903 K033762 000
H834625111 K033762 000
H834625131 K033762 000
H834625121 K033762 000

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