FLEXMATE K500— 510(k) K950755

Substantially Equivalent

Breg, Inc.

FDA 510(k) clearance K950755 for FLEXMATE K500, Substantially Equivalent on 1995-10-05. Applicant: Breg, Inc.. Device class: 1.

Clearance details

Applicant: Breg, Inc.
Product code: Code BXB
Device class: Class 1
Regulation: 21 CFR 890.5380
Advisory panel: Physical Medicine
Date received: 1995-02-17
Decision date: 1995-10-05
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.