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510(k) K123987

IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET by Innovative Medical Technologies, Inc. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2013
Date Received
December 26, 2012
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

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  • K904237 — RAPID IMMOBILIZATION DEVICE OR R.I.D. SYSTEM (May 9, 1991)
  • K854194 — IMT ULTRASONIC STRIDE MONITOR (May 2, 1986)

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