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Request – Redacted Copies of 510(k)s (K130896 & K981624)
Request – Redacted Copies of 510(k)s (K130896 & K981624)
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510(K) Number: K130896
Device Name: VASCULAR PROBE, VASCULAR PROBE ES
Manufacturer: SYNOVIS LIFE TECHNOLOGIES, INC.
Device Classification Name: Dilator, Vessel, Surgical
Regulation Number: 870.4475
Classification Product Code: DWP
Date Received: 04/01/2013
Decision Date: 04/24/2013
Regulation Medical Specialty: Cardiovascular
Request Contents: Request for 510 (k)s redacted copy of K130896 and K981624
Device Name: VASCULAR PROBE, VASCULAR PROBE ES
Manufacturer: SYNOVIS LIFE TECHNOLOGIES, INC.
Device Classification Name: Dilator, Vessel, Surgical
Regulation Number: 870.4475
Classification Product Code: DWP
Date Received: 04/01/2013
Decision Date: 04/24/2013
Regulation Medical Specialty: Cardiovascular
Request Contents: Request for 510 (k)s redacted copy of K130896 and K981624
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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