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FDA 510(k) Application Details - K193409
Device Classification Name
Cleanser, Root Canal
More FDA Info for this Device
510(K) Number
K193409
Device Name
Cleanser, Root Canal
Applicant
Inter-Med/Vista Dental Products
2200 South St. Ste. A
Racine, WI 53404 US
Other 510(k) Applications for this Company
Contact
Alex Johnson
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
KJJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/09/2019
Decision Date
09/09/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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