PERMASORB DISPOSABLE FIXATION DEVICE

Staple, Implantable

C.R. BARD INC

The following data is part of a premarket notification filed by C.r. Bard Inc with the FDA for Permasorb Disposable Fixation Device.

Pre-market Notification Details

Device IDK123718
510k NumberK123718
Device Name:PERMASORB DISPOSABLE FIXATION DEVICE
ClassificationStaple, Implantable
Applicant C.R. BARD INC 100 CROSSINGS BOULEVARD Warwick,  RI  02886
ContactRadhika Pondicherry
CorrespondentRadhika Pondicherry
C.R. BARD INC 100 CROSSINGS BOULEVARD Warwick,  RI  02886
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-04
Decision Date2013-01-22
Summary:summary

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