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FDA 510(k)

HESSLER COLON THERAPY DEVICE

K-Number: K800565 · 1980-06-26

ApplicantHessler Mfg. Co.
Decision Date1980-06-26
Product CodeKPL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HESSLER COLON THERAPY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Hessler Mfg. Co.. It received FDA 510(k) clearance on 1980-06-26 under 510(k) number K800565. 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 HESSLER COLON THERAPY DEVICE?

HESSLER COLON THERAPY DEVICE is a medical device that received FDA 510(k) clearance on 1980-06-26. The listed applicant is Hessler Mfg. Co.. The 510(k) number is K800565.

When did HESSLER COLON THERAPY DEVICE receive FDA 510(k) clearance?

HESSLER COLON THERAPY DEVICE received FDA 510(k) clearance on 1980-06-26, under 510(k) number K800565.

Who is the listed applicant for HESSLER COLON THERAPY DEVICE?

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

What is the FDA product code for HESSLER COLON THERAPY DEVICE?

The FDA product code for HESSLER COLON THERAPY DEVICE 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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