ENDOSCOPIC TRANSMURAL SUTURE NEEDLE SET

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 Endoscopic Transmural Suture Needle Set.

Pre-market Notification Details

Device IDK932118
510k NumberK932118
Device Name:ENDOSCOPIC TRANSMURAL SUTURE NEEDLE SET
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 Received1993-05-03
Decision Date1994-03-17

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