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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name neurological stereotaxic instrument
510(k) Number K122211
Device Name SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS
Applicant
SYNTHES SPINE
1302 WRIGHTS LN EAST
WEST CHESTER,  PA  19380
Applicant Contact HEMAL MEHTA
Correspondent
SYNTHES SPINE
1302 WRIGHTS LN EAST
WEST CHESTER,  PA  19380
Correspondent Contact HEMAL MEHTA
Regulation Number882.4560
Classification Product Code
HAW  
Subsequent Product Code
OLO  
Date Received07/25/2012
Decision Date 12/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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