UFR DIGITAL RETROFIT— 510(k) K875312

Name: FDA 510(k) clearance K875312
Creator: U.S. Food and Drug Administration
Published: 1988-02-19

Substantially Equivalent

Yankee Intl. Medical Research & Mfg., Ltd.

FDA 510(k) clearance K875312 for UFR DIGITAL RETROFIT, Substantially Equivalent on 1988-02-19. Applicant: Yankee Intl. Medical Research & Mfg., Ltd.. Device class: 2.

Clearance details

Applicant: Yankee Intl. Medical Research & Mfg., Ltd.
Product code: Code FJB
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1987-12-29
Decision date: 1988-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manchese, NH, US

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