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FDA 510(k) Application Details - K170802
Device Classification Name
Bone Cement
More FDA Info for this Device
510(K) Number
K170802
Device Name
Bone Cement
Applicant
Synthes (USA) Products, LLC
1301 Goshen Parkway
West Chester, PA 19380 US
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Contact
Christopher J. Medberry
Other 510(k) Applications for this Contact
Regulation Number
888.3027
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Classification Product Code
LOD
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More FDA Info for this Product Code
Date Received
03/17/2017
Decision Date
09/28/2017
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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