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FDA 510(k)

JIMMY JOHN III, COLONIC IRRIGATION SYSTEM

K-Number: K870376 · 1987-03-17

ApplicantColon Therapeutics
Decision Date1987-03-17
Product CodeKPL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

JIMMY JOHN III, COLONIC IRRIGATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Colon Therapeutics. It received FDA 510(k) clearance on 1987-03-17 under 510(k) number K870376. 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 JIMMY JOHN III, COLONIC IRRIGATION SYSTEM?

JIMMY JOHN III, COLONIC IRRIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 1987-03-17. The listed applicant is Colon Therapeutics. The 510(k) number is K870376.

When did JIMMY JOHN III, COLONIC IRRIGATION SYSTEM receive FDA 510(k) clearance?

JIMMY JOHN III, COLONIC IRRIGATION SYSTEM received FDA 510(k) clearance on 1987-03-17, under 510(k) number K870376.

Who is the listed applicant for JIMMY JOHN III, COLONIC IRRIGATION SYSTEM?

The FDA 510(k) record lists Colon Therapeutics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JIMMY JOHN III, COLONIC IRRIGATION SYSTEM?

The FDA product code for JIMMY JOHN III, COLONIC IRRIGATION SYSTEM is KPL.

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Other records listing Colon Therapeutics 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.

K973256JIMMY JOHN III RECTAL NOZZLEK972455JIMMY JOHN III RECTAL NOZZEL, MODEL CITK881720JIMMY JOHN IIIK873948MODIFIED RECTAL NOZZLEK870127MODIFIED JIMMY JOHN IIIK860943JIMMY JOHN III, RECTAL NOZZLE (MODIFICATION)

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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.

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.K051344COLONIC AND ENEMA NOZZLEUltimate Concepts, Inc.

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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