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FDA 510(k)

COLON IRRIGATION DEV.,COLON-A-SUN COLONI

K-Number: K770300 · 1977-03-30

ApplicantSun Product Dist., Inc.
Decision Date1977-03-30
Product CodeFCE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COLON IRRIGATION DEV.,COLON-A-SUN COLONI is the device name listed in this FDA 510(k) record. The listed applicant is Sun Product Dist., Inc.. It received FDA 510(k) clearance on 1977-03-30 under 510(k) number K770300. 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 IRRIGATION DEV.,COLON-A-SUN COLONI?

COLON IRRIGATION DEV.,COLON-A-SUN COLONI is a medical device that received FDA 510(k) clearance on 1977-03-30. The listed applicant is Sun Product Dist., Inc.. The 510(k) number is K770300.

When did COLON IRRIGATION DEV.,COLON-A-SUN COLONI receive FDA 510(k) clearance?

COLON IRRIGATION DEV.,COLON-A-SUN COLONI received FDA 510(k) clearance on 1977-03-30, under 510(k) number K770300.

Who is the listed applicant for COLON IRRIGATION DEV.,COLON-A-SUN COLONI?

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

What is the FDA product code for COLON IRRIGATION DEV.,COLON-A-SUN COLONI?

The FDA product code for COLON IRRIGATION DEV.,COLON-A-SUN COLONI is FCE.

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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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