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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 K904826
Device Name TKO TELESCOPING LITHOTOMY STIRRUP
Applicant
D.L. Nelson and Assoc., Inc.
2902 Marlin Cir.
Atlanta,  GA  30341 -5118
Applicant Contact DENNIS L NELSON
Correspondent
D.L. Nelson and Assoc., Inc.
2902 Marlin Cir.
Atlanta,  GA  30341 -5118
Correspondent Contact DENNIS L NELSON
Regulation Number878.4950
Classification Product Code
FWZ  
Date Received10/25/1990
Decision Date 10/31/1990
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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