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FDA 510(k), K050114, SUPERCATH Z3V
FDA 510(k), K050114, SUPERCATH Z3V
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$149.00 USD
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510(K) Number: K050114
Device Name: SUPERCATH Z3V
Manufacturer: KOZO NAGAYAMAB
Device Classification Name: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Regulation Number: FOZ
Classification Product Code: 01/18/2005
Date Received: 06/09/2005
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: SUPERCATH Z3V
Manufacturer: KOZO NAGAYAMAB
Device Classification Name: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Regulation Number: FOZ
Classification Product Code: 01/18/2005
Date Received: 06/09/2005
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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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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