HESSLER COLON THERAPY DEVICE— 510(k) K800565

Substantially Equivalent

Hessler Mfg. Co.

FDA 510(k) clearance K800565 for HESSLER COLON THERAPY DEVICE, Substantially Equivalent on 1980-06-26. Applicant: Hessler Mfg. Co.. Device class: 2.

Clearance details

Applicant: Hessler Mfg. Co.
Product code: Code KPL
Device class: Class 2
Regulation: 21 CFR 876.5220
Advisory panel: Gastroenterology, Urology
Date received: 1980-03-13
Decision date: 1980-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.