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510(k) K220458

UltraFlo-R Push Button Blood Collection Set by Innovative Medical Technologies, Inc. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2023
Date Received
February 17, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Innovative Medical Technologies, Inc.

  • K123987 — IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET (August 27, 2013)
  • K972969 — QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM (September 22, 1997)
  • K936087 — CARPAL BOX (October 20, 1994)
  • K904237 — RAPID IMMOBILIZATION DEVICE OR R.I.D. SYSTEM (May 9, 1991)
  • K854194 — IMT ULTRASONIC STRIDE MONITOR (May 2, 1986)

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