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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K953409
Device Name LAPAROSCOPIC TROCAR
Applicant
Core Dynamics, Inc.
11222-4 St. Johns
Industrial Pkwy.
Jacksonville,  FL  32246
Applicant Contact PATRICIA H PICKETT
Correspondent
Core Dynamics, Inc.
11222-4 St. Johns
Industrial Pkwy.
Jacksonville,  FL  32246
Correspondent Contact PATRICIA H PICKETT
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/20/1995
Decision Date 10/16/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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