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Found 2 results

510(k) Data Aggregation

K Number

Device Name

INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE

Manufacturer

BOWEL MANAGEMENT SYSTEMS, LLC

Date Cleared

2002-11-06

(30 days)

Product Code

KNT

Regulation Number

876.5980

Why did this record match?

Applicant Name (Manufacturer) :

BOWEL MANAGEMENT SYSTEMS, LLC

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Diversion of fecal matter to minimize external contact with the patient, to facilitate the collection of fecal matter for patients requiring stool management, and to provide access for colonic irrigation to trigger a defecatory response, and administration of enemas/medications.

Device Description

IFMS Catheter (Bowel Mgt Sys) K012113

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K Number

Device Name

INDWELLING FECAL MANAGEMENT SYSTEM

Manufacturer

BOWEL MANAGEMENT SYSTEMS, LLC

Date Cleared

2002-05-03

(301 days)

Product Code

KNT

Regulation Number

876.5980

Why did this record match?

Applicant Name (Manufacturer) :

BOWEL MANAGEMENT SYSTEMS, LLC

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Diversion of fecal matter to minimize external contact with the patient, to facilitate the collection of fecal matter for patients requiring stool management, and to provide access for colonic irrigation to trigger a defecatory response, and administration of enemas/medications.

Device Description

Not Found

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