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FDA 510(k) Application Details - K983104
Device Classification Name
Bone Grafting Material, Synthetic
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510(K) Number
K983104
Device Name
Bone Grafting Material, Synthetic
Applicant
NORIAN CORP.
10260 BUBB RD.
CUPERTINO, CA 95014-4166 US
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Contact
KIM TOMPKINS
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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
09/04/1998
Decision Date
02/12/1999
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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