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510(k) K210051

OTE MPS 045 Multi-purpose Lens Care Solution by Ote North America, LLC — Product Code LPN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2021
Date Received
January 8, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Soft Lens Products
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type

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