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FDA 510(k), K980004, MANAN GENERAL PURPOSE INTRODUCER NEEDLE
FDA 510(k), K980004, MANAN GENERAL PURPOSE INTRODUCER NEEDLE
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510(K) Number: K980004
Device Name: MANAN GENERAL PURPOSE INTRODUCER NEEDLE
Manufacturer: KARL SWARTZ
Device Classification Name: Instrument, Biopsy
Regulation Number: KNW
Classification Product Code: 01/02/1998
Date Received: 01/09/1998
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: MANAN GENERAL PURPOSE INTRODUCER NEEDLE
Manufacturer: KARL SWARTZ
Device Classification Name: Instrument, Biopsy
Regulation Number: KNW
Classification Product Code: 01/02/1998
Date Received: 01/09/1998
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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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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