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510(k) K991904

MODIFICATION OF JMS NEEDLES AND JMS SYRINGES by Jms Co., Ltd. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1999
Date Received
June 4, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Jms Co., Ltd.

  • K002352 — JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE (September 6, 2001)
  • K002394 — JMS APHERESIS NEEDLE SET ACCORDION TYPE (September 5, 2001)
  • K010410 — JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G (June 20, 2001)
  • K010406 — JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G (June 20, 2001)
  • K000843 — MODIFICATION TO JMS APHERESIS NEEDLE (April 10, 2000)
  • K000845 — MODIFICATION TO JMS A.V. FISTULA NEEDLE SET (April 10, 2000)
  • K990510 — JMS APHERESIS NEEDLE (August 30, 1999)
  • K990470 — JMS A. V. FISTULA NEEDLE SET (August 30, 1999)
  • K983707 — JMS DIALYZER PRIMING SET (January 8, 1999)
  • K974902 — JMS APHERESIS NEEDLE (March 30, 1998)

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  • K240355 — FROG (Filter Removal of Glass) (April 18, 2025)
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