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FDA 510(k)

COLON-X

K-Number: K760777 · 1977-01-13

ApplicantCarlton Hygienics, Inc.
Decision Date1977-01-13
Product CodeFCE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COLON-X is the device name listed in this FDA 510(k) record. The listed applicant is Carlton Hygienics, Inc.. It received FDA 510(k) clearance on 1977-01-13 under 510(k) number K760777. The device is classified under product code FCE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLON-X?

COLON-X is a medical device that received FDA 510(k) clearance on 1977-01-13. The listed applicant is Carlton Hygienics, Inc.. The 510(k) number is K760777.

When did COLON-X receive FDA 510(k) clearance?

COLON-X received FDA 510(k) clearance on 1977-01-13, under 510(k) number K760777.

Who is the listed applicant for COLON-X?

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

What is the FDA product code for COLON-X?

The FDA product code for COLON-X is FCE.

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Official Source

View on FDA Database →

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

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