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510(k) K813494

Device
WATERS ILEAL RESERVOIR CATHETER
Applicant
WATERS INSTRUMENTS, INC.
510(k) number
K813494
Product code
KPH  
Decision
Substantially Equivalent (SESE)
Decision date
1981-12-31
Date received
1981-12-14
Regulation
876.5030
Classification name
Catheter, Rectal For Continent Ileostomy
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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