LAPAROSCOPIC KNITTER

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 Laparoscopic Knitter.

Pre-market Notification Details

Device IDK955490
510k NumberK955490
Device Name:LAPAROSCOPIC KNITTER
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 Received1995-11-03
Decision Date1996-01-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10653405043287 K955490 000
10653405043270 K955490 000

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