COLONCARE— 510(k) K030216

Substantially Equivalent

Care Products, Inc.

FDA 510(k) clearance K030216 for COLONCARE, Substantially Equivalent on 2003-04-02. Applicant: Care Products, Inc.. Device class: 2.

Clearance details

Applicant: Care Products, Inc.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 2003-01-21
Decision date: 2003-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waterbury, CT, 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.