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FDA 510(k) Application Details - K201904
Device Classification Name
More FDA Info for this Device
510(K) Number
K201904
Device Name
Monet Curing Laser
Applicant
CAO Group, Inc.
4628 West Skyhawk Drive
West Jordan, UT 84084 US
Other 510(k) Applications for this Company
Contact
Robert K. Larsen
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QNF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/09/2020
Decision Date
11/24/2020
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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