ENDOSCOPIC APPLICATOR

Laparoscope, General & Plastic Surgery

ETHICON INC.

The following data is part of a premarket notification filed by Ethicon Inc. with the FDA for Endoscopic Applicator.

Pre-market Notification Details

Device IDK051732
510k NumberK051732
Device Name:ENDOSCOPIC APPLICATOR
ClassificationLaparoscope, General & Plastic Surgery
Applicant ETHICON INC. ROUTE 22 WEST Somerville,  NJ  08876
ContactPeter Cecchini
CorrespondentPeter Cecchini
ETHICON INC. ROUTE 22 WEST Somerville,  NJ  08876
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-28
Decision Date2005-08-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20705031131955 K051732 000

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