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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 K924606
Device Name BREMER IMAGING TONGS-MRI MODEL
Applicant
BREMER MEDICAL, INC.
C/O HOGAN & HARTSON
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
BREMER MEDICAL, INC.
C/O HOGAN & HARTSON
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number882.5960
Classification Product Code
HAX  
Date Received09/11/1992
Decision Date 09/09/1993
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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