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FDA 510(k), K974814, MANAN(TM) SUPER-CORE BIOPSY NEEDLES
FDA 510(k), K974814, MANAN(TM) SUPER-CORE BIOPSY NEEDLES
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510(K) Number: K974814
Device Name: MANAN(TM) SUPER-CORE BIOPSY NEEDLES
Manufacturer: KARL SWARTZ
Device Classification Name: Instrument, Biopsy
Regulation Number: KNW
Classification Product Code: KXA
Date Received: 12/23/1997
Decision Date: 01/09/1998
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: MANAN(TM) SUPER-CORE BIOPSY NEEDLES
Manufacturer: KARL SWARTZ
Device Classification Name: Instrument, Biopsy
Regulation Number: KNW
Classification Product Code: KXA
Date Received: 12/23/1997
Decision Date: 01/09/1998
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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