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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, Traction, Invasive
510(k) Number K914858
Device Name ACE OPEN-BACK HALO RING
Applicant
Ace Medical Co.
14105 S. Avalon Blvd.
Los Angeles,  CA  90061
Applicant Contact CLAUDE O PERING
Correspondent
Ace Medical Co.
14105 S. Avalon Blvd.
Los Angeles,  CA  90061
Correspondent Contact CLAUDE O PERING
Regulation Number888.3040
Classification Product Code
JEC  
Date Received10/29/1991
Decision Date 11/21/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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