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510(k) K915616

Device
URIHESIVE STRIP
Applicant
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
510(k) number
K915616
Product code
EXI  
Decision
Substantially Equivalent (SESE)
Decision date
1992-01-23
Date received
1991-12-16
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARILYN DREYLING
Address
P.O. Box 4000 Princeton NJ US 08540 08540

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EXI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K971499FEMALE EXTERNAL URINARY COLLECTION POUCHMediquest, Inc.1997-08-28
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

Legacy Summary#

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FDA Review#

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