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510(k) K821401

MALLINCKRODT DIAG. MEDIA WARMER by Forma Scientific, Inc. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1982
Date Received
May 11, 1982
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 Forma Scientific, Inc.

  • K841631 — MODEL 3014 SUCTION UNIT (July 3, 1984)
  • K823356 — READY-BOX BODY-TEMP MEDIA WARMER MALLIN- (December 3, 1982)
  • K812826 — FORMA CH/P GAS PROCESSOR (October 23, 1981)

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