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510(k) K191846

MAXReach Laser Probe by Vortex Surgical, Inc. — Product Code HQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2019
Date Received
July 10, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photocoagulator And Accessories
Device Class
Class II
Regulation Number
886.4690
Review Panel
OP
Submission Type

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