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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 K864746
Device Name BREMER HALO SYSTEM
Applicant
Bremer Orthopedics
433 Margaret St.
Jacksonville,  FL  32204
Applicant Contact PAUL W BREMER
Correspondent
Bremer Orthopedics
433 Margaret St.
Jacksonville,  FL  32204
Correspondent Contact PAUL W BREMER
Regulation Number882.5960
Classification Product Code
HAX  
Date Received12/05/1986
Decision Date 12/22/1986
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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