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FDA 510(k) Application Details - K991004
Device Classification Name
Lock, Wire, And Ligature, Intraoral
More FDA Info for this Device
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
Other 510(k) Applications for this Company
Contact
SHERI L MUSGNUNG
Other 510(k) Applications for this Contact
Regulation Number
872.4600
More FDA Info for this Regulation Number
Classification Product Code
DYX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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