HEATMARKER TIME TEMPERATURE INDICATOR— 510(k) K063759

Name: FDA 510(k) clearance K063759
Creator: U.S. Food and Drug Administration
Published: 2007-08-15

Substantially Equivalent

Temptime Corporation

FDA 510(k) clearance K063759 for HEATMARKER TIME TEMPERATURE INDICATOR, Substantially Equivalent on 2007-08-15. Applicant: Temptime Corporation. Device class: 2.

Clearance details

Applicant: Temptime Corporation
Product code: Code OCI
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2006-12-19
Decision date: 2007-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morris Plains, NJ, US

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