RENALAB TRANSDUCER PROTECTOR, .22 MICRON— 510(k) K812107

Name: FDA 510(k) clearance K812107
Creator: U.S. Food and Drug Administration
Published: 1981-08-20

Substantially Equivalent

Renalab

FDA 510(k) clearance K812107 for RENALAB TRANSDUCER PROTECTOR, .22 MICRON, Substantially Equivalent on 1981-08-20. Applicant: Renalab. Device class: 2.

Clearance details

Applicant: Renalab
Product code: Code FIB
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1981-07-27
Decision date: 1981-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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