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510(k) K241229

Hello,eyes® BIO Plug by Bio Optics Co., Ltd. — Product Code LZU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2024
Date Received
May 2, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plug, Punctum
Device Class
Class U
Regulation Number
Review Panel
OP
Submission Type

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