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FDA 510(k) Application Details - K210881
Device Classification Name
Light, Ultraviolet, Dermatological
More FDA Info for this Device
510(K) Number
K210881
Device Name
Light, Ultraviolet, Dermatological
Applicant
Daavlin Distributing Co.
205 W. Bement Street
Bryan, OH 43506 US
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Contact
Michele Thiel
Other 510(k) Applications for this Contact
Regulation Number
878.4630
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Classification Product Code
FTC
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More FDA Info for this Product Code
Date Received
03/25/2021
Decision Date
06/22/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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