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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Template
510(k) Number K960685
Device Name ORTHODOC PREOPERATIVE PLANNER MODEL 500
Applicant
Integrated Surgical Systems, Inc.
829 W. Stadium Ln.
Sacramento,  CA  95834
Applicant Contact ROBERT VAN OSDEL
Correspondent
Integrated Surgical Systems, Inc.
829 W. Stadium Ln.
Sacramento,  CA  95834
Correspondent Contact ROBERT VAN OSDEL
Regulation Number888.4800
Classification Product Code
HWT  
Subsequent Product Code
JAK  
Date Received02/20/1996
Decision Date 01/17/1997
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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