FDA 510(k) Application Details - K093361

Device Classification Name Motor, Drill, Pneumatic

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510(K) Number K093361
Device Name Motor, Drill, Pneumatic
Applicant SYNTHES (USA)
1301 GOSHEN PKWY.
WEST CHESTER, PA 19380 US
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Contact JILL YELTON
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Regulation Number 882.4370

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Classification Product Code HBB
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Date Received 10/28/2009
Decision Date 04/14/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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