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510(k) K933846

ANGIOGRAPHY SYRINGE KITS by Angiodynamics, Div. E-Z-Em, Inc. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1994
Date Received
August 6, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector And Syringe, Angiographic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type

Other clearances by Angiodynamics, Div. E-Z-Em, Inc.

  • K961763 — PULSE*SPRAY INFUSION SYSTEM (July 17, 1996)
  • K951509 — PULSE*SPRAY INFUSION SYSTEM (June 16, 1995)
  • K951602 — PULSE*SPRAY INFUSION SYSTEM (June 14, 1995)
  • K950907 — PULSE*SPRAY INFUSION SYSTEM (May 17, 1995)
  • K923120 — MICROGUIDE LESION MARKING SYSTEM (September 1, 1992)

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