ABSORBATACK AND APPLICATOR

Staple, Implantable

SORBX, LLC

The following data is part of a premarket notification filed by Sorbx, Llc with the FDA for Absorbatack And Applicator.

Pre-market Notification Details

Device IDK071061
510k NumberK071061
Device Name:ABSORBATACK AND APPLICATOR
ClassificationStaple, Implantable
Applicant SORBX, LLC PO BOX 3614 Ponte Vedra Beach,  FL  32004
ContactMary Lee Willets
CorrespondentMary Lee Willets
SORBX, LLC PO BOX 3614 Ponte Vedra Beach,  FL  32004
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-16
Decision Date2007-05-16

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