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FDA 510(k) Application Details - K220873
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K220873
Device Name
Unit, Operative Dental
Applicant
Lares Research
295 Lockheed Ave
Chico, CA 95973 US
Other 510(k) Applications for this Company
Contact
Bruce Holderbein
Other 510(k) Applications for this Contact
Regulation Number
872.6640
More FDA Info for this Regulation Number
Classification Product Code
EIA
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More FDA Info for this Product Code
Date Received
03/25/2022
Decision Date
12/15/2022
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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