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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 K993021
Device Name METRX SYSTEM
Applicant
Surgical Navigation Technologies, Inc.
530 Compton St.
Broomfield,  CO  80020
Applicant Contact ROGER N WHITE
Correspondent
Surgical Navigation Technologies, Inc.
530 Compton St.
Broomfield,  CO  80020
Correspondent Contact ROGER N WHITE
Regulation Number888.1100
Classification Product Code
HRX  
Date Received09/08/1999
Decision Date 11/10/1999
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
Recalls CDRH Recalls
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