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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Operating Room Accessories Table Tray
510(k) Number K884928
Device Name FREE ARM(TM)
Applicant
Faro Medical Technologies, Inc.
2875 Sabourin St. Quebec
Montreal H4s 1m9,  CA
Applicant Contact FRASER, PHD
Correspondent
Faro Medical Technologies, Inc.
2875 Sabourin St. Quebec
Montreal H4s 1m9,  CA
Correspondent Contact FRASER, PHD
Regulation Number878.4950
Classification Product Code
FWZ  
Date Received11/28/1988
Decision Date 12/15/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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