FDA.reportPublic FDA data

510(k) K935557

Device
URINARY DRAINAGE BAG
Applicant
Puritas Health Care, Inc.
510(k) number
K935557
Product code
KNX
Decision
Substantially Equivalent (SESE)
Decision date
1994-03-07
Date received
1993-11-17
Regulation
876.5250
Classification name
Collector, Urine, (And Accessories) For Indwelling Catheter
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

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 KNX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K110518IBAGFuture Path Medical, LLC2011-06-24
K9733644L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAGMaersk Medical A/S1998-03-17
K972887MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAGMedline Industries, Inc.1997-12-11
K971271BESECURE EXTERNAL URINARY COLLECTION SYSTEMUrology Research Intl., Inc.1997-08-18
K971929AMSINO URINARY LEG BAGAmsino Intl., Inc.1997-08-06
K971764WELCON HUE-VU URINARY DRAINAGE BAGWelcon, Inc.1997-07-29
K964690LIBERTY VALVECleveland Medical Devices, Inc.1997-03-21
K964745AMSINO URINARY DRAINAGE BAGAmsino Intl., Inc.1997-03-18
K962652URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)Customed, Inc.1996-10-04
K960949PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167Bristol-Myers Squibb1996-04-19
K952208PROSYS LEG BAGConvatec, A Division of E.R. Squibb & Sons1995-08-15
K944377ORION'S URINARY DRAINAGE SETRegulatory & Marketing Services, Inc.1994-12-06
K944236NEEDLELESS URINE SAMPLING PORTKendall Healthcare Products Co. Div.Of Tyco Health1994-11-16
K940206BARD URINE COLLECTION PRODUCTS MODIFICATIONC.R. Bard, Inc.1994-09-16
K941447SIMPLA S4, S5, S7Simpla Plastics , Ltd.1994-07-18