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510(k) K973748

TEMPO AND TEMP H20 by Smith — Product Code LGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1998
Date Received
October 1, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Thermal, Infusion Fluid
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Smith

  • K973747 — CONTROLLED TEMPERATURE CABINET SYSTEM (May 7, 1998)
  • K972123 — PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 (July 25, 1997)
  • K971092 — QA-ES (April 23, 1997)
  • K970555 — IL0292 DP ECHOPORT (March 17, 1997)

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