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510(k) K003627

EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET by Exelint International, Co. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2001
Date Received
November 24, 2000
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 Exelint International, Co.

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  • K020189 — EXEL BUTTERFLY SCALP VEIN SET (March 27, 2003)
  • K010197 — EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET (May 14, 2001)
  • K001496 — A.V. FISTULA NEEDLE (August 1, 2000)

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