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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
Recalls CDRH Recalls
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