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510(k) K192418

Phacoemulsification Needle (Tip) and Irrigation Sleeve by Raico, LLC — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2020
Date Received
September 4, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type

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