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FDA 510(k)

COLONCARE

K-Number: K030216 · 2003-04-02

ApplicantCare Products, Inc.
Decision Date2003-04-02
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COLONCARE is the device name listed in this FDA 510(k) record. The listed applicant is Care Products, Inc.. It received FDA 510(k) clearance on 2003-04-02 under 510(k) number K030216. The device is classified under product code KHE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLONCARE?

COLONCARE is a medical device that received FDA 510(k) clearance on 2003-04-02. The listed applicant is Care Products, Inc.. The 510(k) number is K030216.

When did COLONCARE receive FDA 510(k) clearance?

COLONCARE received FDA 510(k) clearance on 2003-04-02, under 510(k) number K030216.

Who is the listed applicant for COLONCARE?

The FDA 510(k) record lists Care Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLONCARE?

The FDA product code for COLONCARE is KHE.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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