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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K962114
Device Name ARTHRO-SURGIMAT
Applicant
W.O.M. World of Medicine GmbH
1300 I St., NW
Suite 900 W.
Washington,  DC  20005
Applicant Contact ROBERT REZNICK
Correspondent
W.O.M. World of Medicine GmbH
1300 I St., NW
Suite 900 W.
Washington,  DC  20005
Correspondent Contact ROBERT REZNICK
Regulation Number888.1100
Classification Product Code
HRX  
Date Received05/31/1996
Decision Date 08/22/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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