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FDA 510(k) Application Details - K110998
Device Classification Name
Cement, Bone, Vertebroplasty
More FDA Info for this Device
510(K) Number
K110998
Device Name
Cement, Bone, Vertebroplasty
Applicant
ALGEA THERAPIES
2560 GENERAL ARMISTEAD AVENUE
AUDUBON, PA 19403 US
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Contact
KELLY J BAKER
Other 510(k) Applications for this Contact
Regulation Number
888.3027
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Classification Product Code
NDN
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More FDA Info for this Product Code
Date Received
04/11/2011
Decision Date
10/25/2011
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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