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510(k) K010958

FISTULOK FISTULA NEEDLE PROTECTION by Diasol, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2001
Date Received
March 30, 2001
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 Diasol, Inc.

  • K130511 — CITRISOL ACID CONCENTRATE (February 10, 2014)
  • K020231 — DIASOL-ADDITIVES (October 21, 2002)
  • K020230 — DIASOL-BICARB (April 23, 2002)
  • K011004 — NEEDLELOK HYPODERMIC NEEDLE PROTECTION (May 24, 2001)
  • K011003 — SAFESTING AND SAFESTING HUB (April 20, 2001)
  • K992999 — DAISY PROTECTED SCALP VEIN SET (November 5, 1999)
  • K993187 — SHELLY PROTECTED AV FISTULA NEEDLE (November 5, 1999)
  • K992653 — SHELLY PROTECTED AV FISTULA NEEDLE (October 27, 1999)
  • K993212 — DRYASOL ACID CONCENTRATE MIX (October 22, 1999)

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