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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 K950063
Device Name WGL ENDOSCOPIC GRASPER*
Applicant
Wilson Greatbatch Technologies, Inc.
10000 Wehrle Dr.
Clarence,  NY  14031
Applicant Contact COLIN P HART
Correspondent
Wilson Greatbatch Technologies, Inc.
10000 Wehrle Dr.
Clarence,  NY  14031
Correspondent Contact COLIN P HART
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/06/1995
Decision Date 01/27/1995
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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