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510(k) Data Aggregation
K Number
K071057Device Name
COLONIC & ENEMA NOZZLE
Manufacturer
TILLER MIND BODY, INC.
Date Cleared
2007-10-05
(172 days)
Product Code
KPL
Regulation Number
876.5220Why did this record match?
Applicant Name (Manufacturer) :
TILLER MIND BODY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Libbe Colonic Nozzle is to be used as the Device/Nozzle inserted into the rectum when used with the LIBBE Lower Bowel Evacuation System. The Device/Nozzle is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examination.
Device Description
The LIBBE Colonic Nozzle device is a plastic, non-sterile, single use product for use as an accessory with lower bowel evacuation systems or enema kits. The Device/Nozzle is intended to be inserted two to three inches into the rectum for instilling water into the colon region. The LIBBE Colonic Nozzle is designed as a one-piece, injection molded, medical grade plastic accessory. The nozzle has an open tip with a slight bulb shape that has two small holes in its wall. The proximal end of the nozzle has a barbed fitting for attachment to plastic tubing from the colonic irrigation, or enema, system.
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K Number
K962259Device Name
LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE)
Manufacturer
TILLER MIND BODY, INC.
Date Cleared
1996-08-29
(78 days)
Product Code
KPL
Regulation Number
876.5220Why did this record match?
Applicant Name (Manufacturer) :
TILLER MIND BODY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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