MAINSTREAM WATER PURIFICATION DEVICE— 510(k) K012716

Name: FDA 510(k) clearance K012716
Creator: U.S. Food and Drug Administration
Published: 2002-05-07

Substantially Equivalent

Prismedical Corp.

FDA 510(k) clearance K012716 for MAINSTREAM WATER PURIFICATION DEVICE, Substantially Equivalent on 2002-05-07. Applicant: Prismedical Corp.. Device class: 2.

Clearance details

Applicant: Prismedical Corp.
Product code: Product code NHV
Device class: Class 2
Regulation: 21 CFR 876.5665
Advisory panel: Gastroenterology, Urology
Date received: 2001-08-15
Decision date: 2002-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Napa, CA, US

Download summary PDF View on FDA.gov ↗

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