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FDA 510(k) Application Details - K210051
Device Classification Name
Accessories, Soft Lens Products
More FDA Info for this Device
510(K) Number
K210051
Device Name
Accessories, Soft Lens Products
Applicant
OTE North America LLC
40 Bayview Ave
Inwood, NY 11096 US
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Contact
Nathan Rosenberg
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Regulation Number
886.5928
More FDA Info for this Regulation Number
Classification Product Code
LPN
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More FDA Info for this Product Code
Date Received
01/08/2021
Decision Date
05/26/2021
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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