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FDA 510(k) Application Details - K192042
Device Classification Name
Barrier, Animal Source, Intraoral
More FDA Info for this Device
510(K) Number
K192042
Device Name
Barrier, Animal Source, Intraoral
Applicant
Geistlich Pharma AG
Bahnhofstrasse 40
Wolhusen CH-6110 CH
Other 510(k) Applications for this Company
Contact
Marco Steiner
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
07/31/2019
Decision Date
08/29/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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