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510(k) K871789

Device
INTECARE PEDIATRIC URINE COLLECTOR
Applicant
MERCURY ENTERPRISES, INC.
510(k) number
K871789
Product code
FFH  
Decision
Substantially Equivalent (SESE)
Decision date
1987-08-10
Date received
1987-05-06
Regulation
876.5250
Classification name
Collector, Urine, Pediatric, For Indwelling Catheter
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM J MASON
Address
1303 Clear Springs Trace, Suite 207 Louisville KY US 40223 40223

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FFH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K905016PEDIATRIC AND INFANT CATH KITSDavol, Inc.1990-12-20
K896581PEDIATRIC DRAIN BAGLaytech Medical Co.1990-01-31

Legacy Summary#

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FDA Review#

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