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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 K954069
Device Name ACE CERVICAL TRACTION HALOZS, TONGS & PINS
Applicant
Ace Medical Co.
2260 E. El Segundo Blvd.
El Segundo,  CA  90245
Applicant Contact NANCY GIEZEN
Correspondent
Ace Medical Co.
2260 E. El Segundo Blvd.
El Segundo,  CA  90245
Correspondent Contact NANCY GIEZEN
Regulation Number882.5960
Classification Product Code
HAX  
Subsequent Product Code
JDW  
Date Received08/30/1995
Decision Date 10/12/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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