ADVANTAGE SINGLE-USE ELECTROSURGICAL ATTACHMENT-J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, BALL TIP, NEEDLE TIP

Electrosurgical, Cutting & Coagulation & Accessories

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Advantage Single-use Electrosurgical Attachment-j-hook Tip, L-hook Tip, Corbitt Spatula Tip, Ball Tip, Needle Tip.

Pre-market Notification Details

Device IDK010444
510k NumberK010444
Device Name:ADVANTAGE SINGLE-USE ELECTROSURGICAL ATTACHMENT-J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, BALL TIP, NEEDLE TIP
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant C.R. BARD, INC. 700 EAST 22ND ST. Lawrence,  KS 
ContactKerry Chunko
CorrespondentRobert Mosenkis
CITECH 5200 BUTLER PIKE Plymouth Meeting,  PA  19462 -1298
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2001-02-14
Decision Date2001-02-28

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