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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cover, burr hole
510(k) Number K042986
Device Name MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM
Applicant
SYNTHES (USA)
1690 RUSSELL RD.
PAOLI,  PA  19301
Applicant Contact LISA M BOYLE
Correspondent
SYNTHES (USA)
1690 RUSSELL RD.
PAOLI,  PA  19301
Correspondent Contact LISA M BOYLE
Regulation Number882.5250
Classification Product Code
GXR  
Subsequent Product Code
HRS  
Date Received10/29/2004
Decision Date 11/17/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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