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510(k) K140362

KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES by Katalyst Surgical, LLC — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2014
Date Received
February 12, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ophthalmic
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type

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