CANNUAL AND TROCAR, SUPERPUBIC

Laparoscope, Gynecologic (and Accessories)

CORE DYNAMICS, INC.

The following data is part of a premarket notification filed by Core Dynamics, Inc. with the FDA for Cannual And Trocar, Superpubic.

Pre-market Notification Details

Device IDK950457
510k NumberK950457
Device Name:CANNUAL AND TROCAR, SUPERPUBIC
ClassificationLaparoscope, Gynecologic (and Accessories)
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 CodeHET  
CFR Regulation Number884.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-03
Decision Date1995-05-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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