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FDA 510(k) Application Details - K010952
Device Classification Name
Barrier, Animal Source, Intraoral
More FDA Info for this Device
510(K) Number
K010952
Device Name
Barrier, Animal Source, Intraoral
Applicant
COOK BIOTECH, INC.
3055 KENT AVE.
WEST LAFAYETTE, IN 47906-1076 US
Other 510(k) Applications for this Company
Contact
MARK BLEYER
Other 510(k) Applications for this Contact
Regulation Number
872.3930
More FDA Info for this Regulation Number
Classification Product Code
NPL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/30/2001
Decision Date
06/10/2002
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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