HYDRO-CLENZ UNIT— 510(k) K863539

Substantially Equivalent

Atlantic Health Group

FDA 510(k) clearance K863539 for HYDRO-CLENZ UNIT, Substantially Equivalent on 1986-10-16. Applicant: Atlantic Health Group. Device class: 2.

Clearance details

Applicant: Atlantic Health Group
Product code: Code KPL
Device class: Class 2
Regulation: 21 CFR 876.5220
Advisory panel: Gastroenterology, Urology
Date received: 1986-09-11
Decision date: 1986-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, 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.