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FDA 510(k)

ENEMA, PHOSPHATE

K-Number: K780613 · 1978-06-02

ApplicantAbco Dealers, Inc.
Decision Date1978-06-02
Product CodeFCE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENEMA, PHOSPHATE is the device name listed in this FDA 510(k) record. The listed applicant is Abco Dealers, Inc.. It received FDA 510(k) clearance on 1978-06-02 under 510(k) number K780613. 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 ENEMA, PHOSPHATE?

ENEMA, PHOSPHATE is a medical device that received FDA 510(k) clearance on 1978-06-02. The listed applicant is Abco Dealers, Inc.. The 510(k) number is K780613.

When did ENEMA, PHOSPHATE receive FDA 510(k) clearance?

ENEMA, PHOSPHATE received FDA 510(k) clearance on 1978-06-02, under 510(k) number K780613.

Who is the listed applicant for ENEMA, PHOSPHATE?

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

What is the FDA product code for ENEMA, PHOSPHATE?

The FDA product code for ENEMA, PHOSPHATE 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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