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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 K993099
Device Name BREMER HALO SYSTEM TITANIUM SKULL PIN
Applicant
DEPUY ACROMED
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Applicant Contact FRANK MASS
Correspondent
DEPUY ACROMED
325 PARAMOUNT DR.
RAYNHAM,  MA  02767 -0350
Correspondent Contact FRANK MASS
Regulation Number888.3040
Classification Product Code
JEC  
Subsequent Product Code
HWC  
Date Received09/16/1999
Decision Date 12/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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