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510(k) K951005

KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2) by Kenex , Ltd. — Product Code IZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 1995
Date Received
February 15, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector, Contrast Medium, Automatic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type

Other clearances by Kenex , Ltd.

  • K951004 — 2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4) (April 10, 1995)
  • K951006 — KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7) (April 3, 1995)
  • K951003 — KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) (April 3, 1995)

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