FREEZER TEETHER— 510(k) K002066

Substantially Equivalent

Cool Baby, Inc.

FDA 510(k) clearance K002066 for FREEZER TEETHER, Substantially Equivalent on 2000-09-26. Applicant: Cool Baby, Inc.. Device class: 2.

Clearance details

Applicant: Cool Baby, Inc.
Product code: Code KKO
Device class: Class 2
Regulation: 21 CFR 872.5550
Advisory panel: Dental
Date received: 2000-07-07
Decision date: 2000-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edmond, OK, US

Download summary PDF View on FDA.gov ↗

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