O2 CARE— 510(k) K882461

Name: FDA 510(k) clearance K882461
Creator: U.S. Food and Drug Administration
Published: 1988-11-28

Substantially Equivalent for Some Indications

Ballard Medical Products

FDA 510(k) clearance K882461 for O2 CARE, Substantially Equivalent for Some Indications on 1988-11-28. Applicant: Ballard Medical Products. Device class: 2.

Clearance details

Applicant: Ballard Medical Products
Product code: Code KPJ
Device class: Class 2
Regulation: 21 CFR 878.5650
Advisory panel: General, Plastic Surgery
Date received: 1988-06-15
Decision date: 1988-11-28
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Midvale, UT, 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.