DAVOL DELIVERY SYSTEM

Laparoscope, General & Plastic Surgery

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Davol Delivery System.

Pre-market Notification Details

Device IDK041641
510k NumberK041641
Device Name:DAVOL DELIVERY SYSTEM
ClassificationLaparoscope, General & Plastic Surgery
Applicant C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston,  RI  02920
ContactSuzanne Lascalza
CorrespondentRobert Mosenkis
CITECH 5200 BUTLER PIKE Plymouth Meeting,  PA  19462 -1298
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2004-06-17
Decision Date2004-07-01
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.