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510(k) K971499

Device
FEMALE EXTERNAL URINARY COLLECTION POUCH
Applicant
MEDIQUEST, INC.
510(k) number
K971499
Product code
EXI  
Decision
Substantially Equivalent (SESE)
Decision date
1997-08-28
Date received
1997-04-25
Regulation
876.5250
Classification name
Device, Paste-on For Incontinence, Sterile
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GREG HOLLAND
Address
3722 Ave. Sausalito Irvine CA US 92606 92606

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EXI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K970443HOLLISTER RETRACTED PENIS POUCHHollister, Inc.1997-02-25
K963950BIODERM EID MALE EXTERNAL INCONTINENCE DEVICEBioderm, Inc.1997-01-10
K931277HOLLISTER PREMIUM URINE COLLECTORHollister, Inc.1993-06-23
K924755CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTIONConvatec, A Division of E.R. Squibb & Sons1993-06-22
K915246CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH)Coloplast A/S1992-02-05
K915616URIHESIVE STRIPConvatec, A Division of E.R. Squibb & Sons1992-01-23

Legacy Summary#

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FDA Review#

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