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510(k) K933522

INTRODUCER NEEDLE (SEVERAL SIZES) by Mediziv Medical Products 1987 , Ltd. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1995
Date Received
July 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Mediziv Medical Products 1987 , Ltd.

  • K933898 — HUBER NEEDLE SETS (September 27, 1995)
  • K933524 — EXTENTION SET (May 23, 1995)
  • K933523 — I.V. FILTER SET (May 19, 1995)

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