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510(k) K893531

Device
CUFF SPECULUM
Applicant
Mountain Medical Equipment, Inc.
510(k) number
K893531
Product code
KPL
Decision
Substantially Equivalent (SESE)
Decision date
1989-06-22
Date received
1989-05-08
Regulation
876.5220
Classification name
Colonic Irrigation System
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JAMES W MORGAN
Address
10488 W. Centennial Rd. Littleton CO US 80127 80127

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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K131852HC-1 AND HC-1 CLASSICTranscendencias Comerciales SL Transcom2014-04-17
K094022THE WATER LILYClearwater Products, LLC2010-06-11
K071057COLONIC & ENEMA NOZZLETiller Mind Body, Inc.2007-10-05
K051344COLONIC AND ENEMA NOZZLEUltimate Concepts, Inc.2005-08-18
K050992CONMED IRRIGATION NOZZLEConmedcorp2005-07-14
K050112PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117Prime Pacific Health Innovations Corporation2005-03-15
K033149ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEMUltimate Concepts, Inc.2004-03-23
K003720ANGEL OF WATER COLON HYDROTHERAPY SYSTEMLifestream Purfication Systems, LLC2002-06-27
K002102GENTLE COLONICS IRRIGATION SYSTEMGentle Colonics, Inc.2002-02-06
K000031AQUANET, MODEL EC 2000Prime Pacific Health Innovations Corporation2001-09-10
K000388CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)Clearwater Colon Hydrotherapy, Inc.2000-08-08