CKHEMO, MODEL CKHEMO VERSION 1.0— 510(k) K992255

Substantially Equivalent

Csam, Inc.

FDA 510(k) clearance K992255 for CKHEMO, MODEL CKHEMO VERSION 1.0, Substantially Equivalent on 1999-11-30. Applicant: Csam, Inc.. Device class: 2.

Clearance details

Applicant: Csam, Inc.
Product code: Code FKP
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1999-07-06
Decision date: 1999-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bettendorf, IA, 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.