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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 K942910
Device Name DEEPVISON
Applicant
Automated Medical Products Corp.
1920 N St. Northwest
Suite 650
Washington,  DC  20036
Applicant Contact BRUCE F MACKLER
Correspondent
Automated Medical Products Corp.
1920 N St. Northwest
Suite 650
Washington,  DC  20036
Correspondent Contact BRUCE F MACKLER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/21/1994
Decision Date 07/21/1995
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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