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FDA 510(k)

ENEMA BULB

K-Number: K904534 · 1990-12-21

ApplicantR.A.C., Inc.
Decision Date1990-12-21
Product CodeFCE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENEMA BULB is the device name listed in this FDA 510(k) record. The listed applicant is R.A.C., Inc.. It received FDA 510(k) clearance on 1990-12-21 under 510(k) number K904534. 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 BULB?

ENEMA BULB is a medical device that received FDA 510(k) clearance on 1990-12-21. The listed applicant is R.A.C., Inc.. The 510(k) number is K904534.

When did ENEMA BULB receive FDA 510(k) clearance?

ENEMA BULB received FDA 510(k) clearance on 1990-12-21, under 510(k) number K904534.

Who is the listed applicant for ENEMA BULB?

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

What is the FDA product code for ENEMA BULB?

The FDA product code for ENEMA BULB is FCE.

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Related Devices (Code: FCE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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