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FDA 510(k), K162640, iVitri EZ
FDA 510(k), K162640, iVitri EZ
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$149.00 USD
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510(K) Number: K162640
Device Name: iVitri EZ
Manufacturer: REPROBITECH CORP.
Device Classification Name: labware, assisted reproduction
Regulation Number: 884.6160
Classification Product Code: MQK
Date Received: 09/22/2016
Decision Date: 06/30/2017
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: iVitri EZ
Manufacturer: REPROBITECH CORP.
Device Classification Name: labware, assisted reproduction
Regulation Number: 884.6160
Classification Product Code: MQK
Date Received: 09/22/2016
Decision Date: 06/30/2017
Regulation Medical Specialty: Obstetrics/Gynecology
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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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