FDA 510(k), K193376, Visalis V500, Visalis S500
FDA 510(k), K193376, Visalis V500, Visalis S500
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510(K) Number: K193376
Device Name: Visalis V500, Visalis S500
Manufacturer: Carl Zeiss Meditec AG
Device Classification Name: unit, phacofragmentation
Regulation Number: 886.4670
Classification Product Code: HQC
Date Received: 12/05/2019
Decision Date: 06/15/2020
Regulation Medical Specialty: Ophthalmic
Device Name: Visalis V500, Visalis S500
Manufacturer: Carl Zeiss Meditec AG
Device Classification Name: unit, phacofragmentation
Regulation Number: 886.4670
Classification Product Code: HQC
Date Received: 12/05/2019
Decision Date: 06/15/2020
Regulation Medical Specialty: Ophthalmic
- 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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