POLAR CARE (MODEL 500/50000)— 510(k) K961855

Substantially Equivalent

Breg, Inc.

FDA 510(k) clearance K961855 for POLAR CARE (MODEL 500/50000), Substantially Equivalent on 1996-08-09. Applicant: Breg, Inc.. Device class: 2.

Clearance details

Applicant: Breg, Inc.
Product code: Code ILO
Device class: Class 2
Regulation: 21 CFR 890.5720
Advisory panel: Physical Medicine
Date received: 1996-05-14
Decision date: 1996-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vista, CA, 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.