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510(k) K090426

VAKU-8 BLOOD COLLECTION NEEDLES by Myco Medical Supplies, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2009
Date Received
February 19, 2009
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 Myco Medical Supplies, Inc.

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  • K042504 — CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER (January 19, 2006)
  • K000592 — UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET (April 12, 2001)
  • K990519 — PHOENIX EPIDURAL & SPINAL NEEDLES (June 2, 2000)
  • K982646 — AILEE SUTURES AND AILEE NEEDLES (June 2, 1999)
  • K990388 — TUTOPLUS IV ADMINISTRATION SET (March 29, 1999)
  • K982098 — TUTODROP 1 AND TUTODROP 2 (March 1, 1999)
  • K963364 — GLASS VAN GLASS SYRINGES (May 1, 1998)
  • K953252 — DISPOSABLE SCALP VEIN INFUSION SET (November 26, 1996)

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