510(k) K170520

HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ by Alcon Research, Ltd. — Product Code MLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2017
Date Received
February 22, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vitrectomy, Instrument Cutter
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type