FIRM MASTER— 510(k) K905195

Substantially Equivalent

Bak Medical Products

FDA 510(k) clearance K905195 for FIRM MASTER, Substantially Equivalent on 1991-02-01. Applicant: Bak Medical Products. Device class: 2.

Clearance details

Applicant: Bak Medical Products
Product code: Code LKY
Device class: Class 2
Regulation: 21 CFR 876.5020
Advisory panel: Gastroenterology, Urology
Date received: 1990-11-19
Decision date: 1991-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Martinez, 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.