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FDA 510(k) Application Details - K192612
Device Classification Name
Barrier, Animal Source, Intraoral
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510(K) Number
K192612
Device Name
Barrier, Animal Source, Intraoral
Applicant
Kerecis Limited
Eyrargata 2
Isafjordur 400 IS
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Contact
Gudmundur Fertram Sigurjonsson
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
09/20/2019
Decision Date
11/13/2020
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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