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FDA 510(k)

COLONIC AND ENEMA NOZZLE

K-Number: K051344 · 2005-08-18

ApplicantUltimate Concepts, Inc.
Decision Date2005-08-18
Product CodeKPL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COLONIC AND ENEMA NOZZLE is the device name listed in this FDA 510(k) record. The listed applicant is Ultimate Concepts, Inc.. It received FDA 510(k) clearance on 2005-08-18 under 510(k) number K051344. 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 COLONIC AND ENEMA NOZZLE?

COLONIC AND ENEMA NOZZLE is a medical device that received FDA 510(k) clearance on 2005-08-18. The listed applicant is Ultimate Concepts, Inc.. The 510(k) number is K051344.

When did COLONIC AND ENEMA NOZZLE receive FDA 510(k) clearance?

COLONIC AND ENEMA NOZZLE received FDA 510(k) clearance on 2005-08-18, under 510(k) number K051344.

Who is the listed applicant for COLONIC AND ENEMA NOZZLE?

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

What is the FDA product code for COLONIC AND ENEMA NOZZLE?

The FDA product code for COLONIC AND ENEMA NOZZLE is KPL.

Related Clinical Trials

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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Other records listing Ultimate Concepts, Inc. as applicant

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.

K033149ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEMK943202EASSUN HI-TECH OPTICS

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.

K201861Bio Fluff SystemGnali Bocia S.R.L.K180800Colonic Plus Regular, Small, and Straight Shape HydrokitColonic PlusK152834Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10Colonplus Equipments & Speculums, S.L.K094022THE WATER LILYClearwater Products, LLCK071057COLONIC & ENEMA NOZZLETiller Mind Body, Inc.K050992CONMED IRRIGATION NOZZLEConmedcorp

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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