RIWOLITH 2135— 510(k) K822644

Name: FDA 510(k) clearance K822644
Creator: U.S. Food and Drug Administration
Published: 1982-09-21

Substantially Equivalent

R. Wolf Medical Instruments Corp.

FDA 510(k) clearance K822644 for RIWOLITH 2135, Substantially Equivalent on 1982-09-21. Applicant: R. Wolf Medical Instruments Corp.. Device class: 2.

Clearance details

Applicant: R. Wolf Medical Instruments Corp.
Product code: Code FFK
Device class: Class 2
Regulation: 21 CFR 876.4480
Advisory panel: Gastroenterology, Urology
Date received: 1982-09-01
Decision date: 1982-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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