CORE AUDIBLE TROCAR II


Device Classification Name

laparoscope, general & plastic surgery

510(k) Number K992250
Device Name CORE AUDIBLE TROCAR II
Applicant
CORE DYNAMICS, INC.
11222 st. johns ind. pkwy.
north
jacksonville, 
FL 
32246 -6675

Applicant Contact thomas m mcintosh
Correspondent
CORE DYNAMICS, INC.
11222 st. johns ind. pkwy.
north
jacksonville, 
FL 
32246 -6675

Correspodent Contact thomas m mcintosh
Regulation Number 876.1500
Classification Product Code
GCJ  
Date Received 07/06/1999
Decision Date 09/24/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No