FDA 510(k) Application Details - K991004

Device Classification Name Lock, Wire, And Ligature, Intraoral

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510(K) Number K991004
Device Name Lock, Wire, And Ligature, Intraoral
Applicant SYNTHES (USA)
P.O. BOX 1766
1690 RUSSELL ROAD
PAOLI, PA 19301-1222 US
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Contact SHERI L MUSGNUNG
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Regulation Number 872.4600

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Classification Product Code DYX
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Date Received 03/25/1999
Decision Date 06/23/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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