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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 K050027
Device Name LAPAROCISION SCOPE CONTROLLER SYSTEM
Applicant
Gmp/Companies, Inc.
One E. Broward Blvd.
Suite 1701
Fort Lauderdale,  FL  33301
Applicant Contact RALPH JUGO
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/06/2005
Decision Date 01/27/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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