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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 K090340
Device Name FREEHAND
Applicant
PROSURGICS LIMITED
377 ROUTE 17S
HASBROUCK HEIGHTS,  NJ  07604
Applicant Contact GEROGE MYERS
Correspondent
PROSURGICS LIMITED
377 ROUTE 17S
HASBROUCK HEIGHTS,  NJ  07604
Correspondent Contact GEROGE MYERS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/10/2009
Decision Date 05/22/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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