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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K950683
Device Name ARTHROGRAM TRAY
Applicant
Surgical Technologies, Inc.
2801 S. Decker Lake Ln.
Salt Lake City,  UT  84119
Applicant Contact JOHN E LINCOLN
Correspondent
Surgical Technologies, Inc.
2801 S. Decker Lake Ln.
Salt Lake City,  UT  84119
Correspondent Contact JOHN E LINCOLN
Regulation Number892.1650
Classification Product Code
JAA  
Date Received02/14/1995
Decision Date 05/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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