CORE DYNAMICS' LAPAROSCOPIC SMOKE ELIMINATOR

Laparoscope, General & Plastic Surgery

CORE DYNAMICS, INC.

The following data is part of a premarket notification filed by Core Dynamics, Inc. with the FDA for Core Dynamics' Laparoscopic Smoke Eliminator.

Pre-market Notification Details

Device IDK943172
510k NumberK943172
Device Name:CORE DYNAMICS' LAPAROSCOPIC SMOKE ELIMINATOR
ClassificationLaparoscope, General & Plastic Surgery
Applicant CORE DYNAMICS, INC. 11222-4 ST. JOHNS INDUSTRIAL PARKWAY Jacksonville,  FL  32246
ContactBill Dennis
CorrespondentBill Dennis
CORE DYNAMICS, INC. 11222-4 ST. JOHNS INDUSTRIAL PARKWAY Jacksonville,  FL  32246
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-20
Decision Date1994-07-28

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