ISONEPHROS-PEDIATRIC, STANDARD, OPTIMUM— 510(k) K801451

Name: FDA 510(k) clearance K801451
Creator: U.S. Food and Drug Administration
Published: 1980-09-26

Substantially Equivalent

Medical, Inc.

FDA 510(k) clearance K801451 for ISONEPHROS-PEDIATRIC, STANDARD, OPTIMUM, Substantially Equivalent on 1980-09-26. Applicant: Medical, Inc.. Device class: 2.

Clearance details

Applicant: Medical, Inc.
Product code: Code FJG
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1980-06-23
Decision date: 1980-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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