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FDA 510(k) Application Details - K210300
Device Classification Name
Accessories, Solution, Ultrasonic Cleaners For Lenses
More FDA Info for this Device
510(K) Number
K210300
Device Name
Accessories, Solution, Ultrasonic Cleaners For Lenses
Applicant
VueSonic, LLC
1234 Washington Ave., #205
Miami Beach, FL 33139 US
Other 510(k) Applications for this Company
Contact
Sheri Ker
Other 510(k) Applications for this Contact
Regulation Number
886.5928
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Classification Product Code
LYL
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More FDA Info for this Product Code
Date Received
02/03/2021
Decision Date
04/01/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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