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FDA 510(k)

DOTOLO COLON HYDROTHERAPY INSTRUMENT

K-Number: K870534 · 1987-06-18

ApplicantDotolo Research Corp. C/O Keller and Heckman
Decision Date1987-06-18
Product CodeKPL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DOTOLO COLON HYDROTHERAPY INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Dotolo Research Corp. C/O Keller and Heckman. It received FDA 510(k) clearance on 1987-06-18 under 510(k) number K870534. 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 DOTOLO COLON HYDROTHERAPY INSTRUMENT?

DOTOLO COLON HYDROTHERAPY INSTRUMENT is a medical device that received FDA 510(k) clearance on 1987-06-18. The listed applicant is Dotolo Research Corp. C/O Keller and Heckman. The 510(k) number is K870534.

When did DOTOLO COLON HYDROTHERAPY INSTRUMENT receive FDA 510(k) clearance?

DOTOLO COLON HYDROTHERAPY INSTRUMENT received FDA 510(k) clearance on 1987-06-18, under 510(k) number K870534.

Who is the listed applicant for DOTOLO COLON HYDROTHERAPY INSTRUMENT?

The FDA 510(k) record lists Dotolo Research Corp. C/O Keller and Heckman as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DOTOLO COLON HYDROTHERAPY INSTRUMENT?

The FDA product code for DOTOLO COLON HYDROTHERAPY INSTRUMENT 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.

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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