T-300 COOLER— 510(k) K945468

Substantially Equivalent

Temptek, Inc.

FDA 510(k) clearance K945468 for T-300 COOLER, Substantially Equivalent on 1995-06-19. Applicant: Temptek, Inc.. Device class: 2.

Clearance details

Applicant: Temptek, Inc.
Product code: Code ILO
Device class: Class 2
Regulation: 21 CFR 890.5720
Advisory panel: Physical Medicine
Date received: 1994-11-08
Decision date: 1995-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carrollton, TX, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.