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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tong, Skull For Traction
510(k) Number K861470
Device Name #CTO 100 (CERVICAL TRACTION ORTHOSIS 100)
Applicant
Applied Medical Systems
727 N. 19th St.
Allentown,  PA  18104
Applicant Contact JACK M POTTS
Correspondent
Applied Medical Systems
727 N. 19th St.
Allentown,  PA  18104
Correspondent Contact JACK M POTTS
Regulation Number882.5960
Classification Product Code
HAX  
Date Received04/22/1986
Decision Date 05/02/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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