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510(k) K935578

Device
URINE METER
Applicant
PURITAS HEALTH CARE, INC.
510(k) number
K935578
Product code
EXR  
Decision
Substantially Equivalent (SESE)
Decision date
1993-12-17
Date received
1993-11-18
Regulation
876.1800
Classification name
Urinometer, Mechanical
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
THOMAS P DIMAIO
Address
219 Kent Rd., Suite 20 New Milford CT US 06776 06776

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EXR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K934142URINARY DRAINAGE BAGKey Medical Services, Inc.1994-05-17
K911258KENDALL PEDIATRIC URINE METERKendall Healthcare Products Co. Div.Of Tyco Health1991-04-25
K896732UNOMETER 500Unoplast A/S1990-11-02
K870240COMPRESS AND SKULLCAP, HEAD DRESSINGFraass Survival Systems, Inc.1987-02-20
K771561DOVER URINE METERWill Ross Co.1977-09-07
K770423URINE TESTER, MODEL NO. 707Brother Scientific Products, Inc.1977-06-03
K770939URINE TESTER, MODEL 701Brother Scientific Products, Inc.1977-06-03
K761083BARD URINE METER W/ BAGC.R. Bard, Inc.1977-01-26

Legacy Summary#

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FDA Review#

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