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510(k) K911383

HOTLINE FLUID WARMER by Level 1 Technologies, Inc. — Product Code LGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1991
Date Received
March 28, 1991
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 Level 1 Technologies, Inc.

  • K942844 — LEVEL 1 BLOOD STREAM RECOVERY SYSTEM (April 26, 1996)
  • K942271 — LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE (July 12, 1995)
  • K936223 — PRESSURE IRRIGATING SYSTEM (May 12, 1994)
  • K873435 — LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET (October 5, 1987)

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