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FDA 510(k) Application Details - K962548
Device Classification Name
Bone Grafting Material, Synthetic
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510(K) Number
K962548
Device Name
Bone Grafting Material, Synthetic
Applicant
ETEX CORP.
38 SIDNEY ST., 3FLR
THE CLARK BLDG.
CAMBRIDGE, MA 02139 US
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Contact
DOSUK D LEE
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Regulation Number
872.3930
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Classification Product Code
LYC
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More FDA Info for this Product Code
Date Received
06/28/1996
Decision Date
08/05/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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