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FDA 510(k), K191252, Gem FlowCoupler System
FDA 510(k), K191252, Gem FlowCoupler System
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510(K) Number: K191252
Device Name: Gem FlowCoupler System
Manufacturer: Baxter/ Synovis Micro Companies Alliance Inc.
Device Classification Name: device, anastomotic, microvascular
Regulation Number: 878.4300
Classification Product Code: MVR
Date Received: 05/09/2019
Decision Date: 07/09/2019
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Gem FlowCoupler System
Manufacturer: Baxter/ Synovis Micro Companies Alliance Inc.
Device Classification Name: device, anastomotic, microvascular
Regulation Number: 878.4300
Classification Product Code: MVR
Date Received: 05/09/2019
Decision Date: 07/09/2019
Regulation Medical Specialty: General & Plastic Surgery
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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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