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FDA 510(k)

NON-RETENTION ENEMA SYSTEM

K-Number: K781923 · 1979-08-03

ApplicantHudson Kendale Assoc., Inc.
Decision Date1979-08-03
Product CodeKPL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NON-RETENTION ENEMA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hudson Kendale Assoc., Inc.. It received FDA 510(k) clearance on 1979-08-03 under 510(k) number K781923. The device is classified under product code KPL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NON-RETENTION ENEMA SYSTEM?

NON-RETENTION ENEMA SYSTEM is a medical device that received FDA 510(k) clearance on 1979-08-03. The listed applicant is Hudson Kendale Assoc., Inc.. The 510(k) number is K781923.

When did NON-RETENTION ENEMA SYSTEM receive FDA 510(k) clearance?

NON-RETENTION ENEMA SYSTEM received FDA 510(k) clearance on 1979-08-03, under 510(k) number K781923.

Who is the listed applicant for NON-RETENTION ENEMA SYSTEM?

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

What is the FDA product code for NON-RETENTION ENEMA SYSTEM?

The FDA product code for NON-RETENTION ENEMA SYSTEM is KPL.

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Related Devices (Code: KPL)

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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