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510(k) K896581

Device
PEDIATRIC DRAIN BAG
Applicant
LAYTECH MEDICAL CO.
510(k) number
K896581
Product code
FFH  
Decision
Substantially Equivalent (SESE)
Decision date
1990-01-31
Date received
1989-11-17
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
CATHERINE S LAYTON
Address
816 Nichols Arlington Heights IL US 60004 60004

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
K871789INTECARE PEDIATRIC URINE COLLECTORMercury Enterprises, Inc.1987-08-10

Legacy Summary#

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FDA Review#

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