BLO2X OXYGEN BLOCKER— 510(k) K102526

Substantially Equivalent

Pascal Co., Inc.

FDA 510(k) clearance K102526 for BLO2X OXYGEN BLOCKER, Substantially Equivalent on 2010-10-22. Applicant: Pascal Co., Inc.. Device class: 2.

Clearance details

Applicant: Pascal Co., Inc.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2010-09-02
Decision date: 2010-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, 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.