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510(k) K900847

Device
ENEMA KIT 'Y' DESIGN
Applicant
CUSTOM MEDICAL PRODUCTS, LTD.
510(k) number
K900847
Product code
FCE  
Decision
Substantially Equivalent (SESE)
Decision date
1990-04-13
Date received
1990-02-22
Regulation
876.5210
Classification name
Enema Kit
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
GEORGE C SCHULER
Address
4101 Spring Mill Way Maineville OH US 45039 45039

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FCE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K974042AMSURE CLEANSING ENEMA SETAmsino Intl., Inc.1997-12-19
K931896PRO-FLO SYSTEMLafayette Pharmacal, Inc.1993-08-26
K9223984 SURE TM ENEMA BAG SETBoston Pacific Medical, Inc.1993-06-17
K913620ENEMA KITYork County Blind Center1991-11-01
K904534ENEMA BULBR.A.C., Inc.1990-12-21
K901182ENEMA BAG SETOrion Life Systems, Inc.1990-06-28
K901179ENEMA BUCKET SETOrion Life Systems, Inc.1990-06-28
K900848ENEMA KIT 'STRAIGHT' DESIGNCustom Medical Products, Ltd.1990-04-13
K881218GENT-L-KARE CLEANSING ENEMA SETGeneva Laboratories, Inc.1988-07-28
K880337MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700Plasco, Inc.1988-04-14
K872992SPS SUSPENSION ENEMA KITCarolina Medical Products Co.1987-09-17
K870796MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SYPlasco, Inc.1987-04-01
K870019THE LAHR BALLOONPlasco, Inc.1987-04-01
K843792VAN JON SUPER CLYSTER(KIT, ENEMAVan Jon Co.1985-04-22
K842130G.I. CLEANSING KITMmi, Inc.1984-08-08

Legacy Summary#

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FDA Review#

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