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FDA 510(k) Application Details - K970779
Device Classification Name
Cement Obturator
More FDA Info for this Device
510(K) Number
K970779
Device Name
Cement Obturator
Applicant
OSTEONICS CORP.
59 ROUTE 17
ALLENDALE, NJ 07401-1677 US
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Contact
KATE SUTTON
Other 510(k) Applications for this Contact
Regulation Number
878.3300
More FDA Info for this Regulation Number
Classification Product Code
LZN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/04/1997
Decision Date
05/09/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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