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510(k) K790835

DYNAJECT by Atomic Products Corp. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1979
Date Received
April 30, 1979
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

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  • K895799 — RECTILINEAR SCANNER MODEL #187-270 (February 1, 1990)
  • K884312 — ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270 (February 16, 1989)
  • K871868 — VENTI-SCAN II (April 11, 1988)
  • K874332 — MRI STRETCHER (January 5, 1988)

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