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FDA 510(k) Application Details - K090216
Device Classification Name
Barrier, Animal Source, Intraoral
More FDA Info for this Device
510(K) Number
K090216
Device Name
Barrier, Animal Source, Intraoral
Applicant
COLLAGEN MATRIX, INC.
509 COMMERCE ST.
FRANKLIN LAKES, NJ 07417 US
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Contact
PEGGY HANSEN
Other 510(k) Applications for this Contact
Regulation Number
872.3930
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Classification Product Code
NPL
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More FDA Info for this Product Code
Date Received
01/29/2009
Decision Date
09/18/2009
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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