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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 K992190
Device Name CORE POUCH
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
Correspondent Contact THOMAS M MCINTOSH
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/29/1999
Decision Date 09/01/1999
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
Predetermined Change
Control Plan Authorized		 No
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