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FDA 510(k) Application Details - K143327
Device Classification Name
Barrier, Synthetic, Intraoral
More FDA Info for this Device
510(K) Number
K143327
Device Name
Barrier, Synthetic, Intraoral
Applicant
Neoss Ltd
Windsor House Cornwall Road
Harrogate Hg1 2PW GB
Other 510(k) Applications for this Company
Contact
Karin Darle Olsson
Other 510(k) Applications for this Contact
Regulation Number
872.3930
More FDA Info for this Regulation Number
Classification Product Code
NPK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/20/2014
Decision Date
04/13/2015
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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