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FDA 510(k) Application Details - K103820
Device Classification Name
Bone Grafting Material, Synthetic
More FDA Info for this Device
510(K) Number
K103820
Device Name
Bone Grafting Material, Synthetic
Applicant
CERAMISYS LTD
344 ANNABELLE POINT ROAD
CENTERVILLE, MA 02632-2402 US
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Contact
HILLARD W WELCH
Other 510(k) Applications for this Contact
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
12/30/2010
Decision Date
11/03/2011
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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