TRANSCOM COLON HYDROTHERAPY MODEL HC-2000— 510(k) K970482

Name: FDA 510(k) clearance K970482
Creator: U.S. Food and Drug Administration
Published: 1997-10-31

Substantially Equivalent

Srs Intl.

FDA 510(k) clearance K970482 for TRANSCOM COLON HYDROTHERAPY MODEL HC-2000, Substantially Equivalent on 1997-10-31. Applicant: Srs Intl.. Device class: 2.

Clearance details

Applicant: Srs Intl.
Product code: Code KPL
Device class: Class 2
Regulation: 21 CFR 876.5220
Advisory panel: Gastroenterology, Urology
Date received: 1997-02-10
Decision date: 1997-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.