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FDA 510(k) Application Details - K081558
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K081558
Device Name
Filler, Bone Void, Calcium Compound
Applicant
PIONEER SURGICAL TECHNOLOGY
375 RIVER PARK CIRCLE
MARQUETTE, MI 49855-0627 US
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Contact
JONATHAN GILBERT
Other 510(k) Applications for this Contact
Regulation Number
888.3045
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Classification Product Code
MQV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/03/2008
Decision Date
08/25/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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