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FDA 510(k) Application Details - K122637
Device Classification Name
Light, Surgical, Fiberoptic
More FDA Info for this Device
510(K) Number
K122637
Device Name
Light, Surgical, Fiberoptic
Applicant
STRYKER SPINE
2 PEARL COURT
ALLENDALE, NJ 07401 US
Other 510(k) Applications for this Company
Contact
TINA MORNAK
Other 510(k) Applications for this Contact
Regulation Number
878.4580
More FDA Info for this Regulation Number
Classification Product Code
FST
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More FDA Info for this Product Code
Date Received
08/29/2012
Decision Date
11/01/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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