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510(k) K823356

READY-BOX BODY-TEMP MEDIA WARMER MALLIN- by Forma Scientific, Inc. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1982
Date Received
November 9, 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)
  • K821401 — MALLINCKRODT DIAG. MEDIA WARMER (June 17, 1982)
  • K812826 — FORMA CH/P GAS PROCESSOR (October 23, 1981)

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