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FDA 510(k), K170520, HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+
FDA 510(k), K170520, HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+
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510(K) Number: K170520
Device Name: HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+
Manufacturer: Karen Mudd
Device Classification Name: Vitrectomy, Instrument Cutter
Regulation Number: MLZ
Classification Product Code: 02/22/2017
Date Received: 03/22/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
Device Name: HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+
Manufacturer: Karen Mudd
Device Classification Name: Vitrectomy, Instrument Cutter
Regulation Number: MLZ
Classification Product Code: 02/22/2017
Date Received: 03/22/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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