B-L RED(TM) DISCS— 510(k) K950346

Substantially Equivalent

Oxis Intl., Inc.

FDA 510(k) clearance K950346 for B-L RED(TM) DISCS, Substantially Equivalent on 1995-05-05. Applicant: Oxis Intl., Inc.. Device class: 1.

Clearance details

Applicant: Oxis Intl., Inc.
Product code: Code JTO
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1995-01-27
Decision date: 1995-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

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