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510(k) K902221

MODIFIED ANGIOGRAPHIC INJECTOR AND SYRINGE by Mallinckrodt Group, Inc. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1990
Date Received
May 17, 1990
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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  • K905789 — FRANKLIN 9000 WALL STAND (May 20, 1991)
  • K904145 — HYDRA VISION UROLOGICAL X-RAY SYSTEM (December 13, 1990)

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