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Found 2 results

510(k) Data Aggregation

K Number

Device Name

JIMMY JOHN III RECTAL NOZZLE

Manufacturer

COLON THERAPEUTICS

Date Cleared

1997-09-29

(35 days)

Product Code

KPL

Regulation Number

876.5220

Why did this record match?

Applicant Name (Manufacturer) :

COLON THERAPEUTICS

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Intended for use in Colon Irrigation with any colon irrigation system. Class II - These devices are intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.

Device Description

JIMMY JOHN III RECTAL NOZZLE

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K Number

Device Name

JIMMY JOHN III RECTAL NOZZEL, MODEL CIT

Manufacturer

COLON THERAPEUTICS

Date Cleared

1997-09-09

(70 days)

Product Code

KPL

Regulation Number

876.5220

Why did this record match?

Applicant Name (Manufacturer) :

COLON THERAPEUTICS

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Intended for use in Colon Irrigation with any colon irrigation system. Class II - These devices are intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.

Device Description

JIMMY JOHN III RECTAL NOZZLE MODEL CIT

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