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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K950457
Device Name CANNUAL AND TROCAR, SUPERPUBIC
Applicant
Core Dynamics, Inc.
11222-4 St. Johns
Industrial Pkwy.
Jacksonville,  FL  32246
Applicant Contact BILL DENNIS
Correspondent
Core Dynamics, Inc.
11222-4 St. Johns
Industrial Pkwy.
Jacksonville,  FL  32246
Correspondent Contact BILL DENNIS
Regulation Number884.1720
Classification Product Code
HET  
Date Received02/03/1995
Decision Date 05/05/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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