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510(k) K945204

Device
URINE COLLECTOR & ACCESSORIES
Applicant
NELMED CORP.
510(k) number
K945204
Product code
FAQ  
Decision
Substantially Equivalent (SESE)
Decision date
1994-11-02
Date received
1994-10-25
Regulation
876.5250
Classification name
Bag, Urine Collection, Leg, For External Use, Sterile
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ERIK NELSON
Address
35 Hawthorne St. North Attleboro MA US 02760 02760

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FAQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K962604PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZINGConvatec, A Division of E.R. Squibb & Sons1996-07-18
K960217CPR URINE BAGCustom Pack Reliability1996-03-28
K955609CONVEEN URINE BAG - STERILEColoplast Corp.1995-12-29
K953767PROSYS BEDSIDE DRAINAGE BAGConvatec, A Division of E.R. Squibb & Sons1995-12-20
K953783CONVEEN LEG BAG STRAPColoplast Corp.1995-09-13
K951945PROSYS LEG BAGConvatec, A Division of E.R. Squibb & Sons1995-05-25
K934052ALPINE REUSABLE LEG BAGSSierra Laboratories, Inc.1994-01-07
K931727URINARY DRAINAGE BAG CADDYNeotech Products, Inc.1993-07-23
K926035BARD LEG BAG HOLDERC.R. Bard, Inc.1992-12-17
K924406CONVEEN(R) LEG BAG(500 ML)Coloplast A/S1992-10-30
K903611ILC LEG BAG HOLDERInman Liebelt Corp.1990-10-26
K901219EXTERNAL LEG BAGOrion Life Systems, Inc.1990-06-27
K896129URINARY LEG BAGCypress Medical Products, Ltd.1990-04-16
K8967284 SURE URINARY LEG BAGThe Boston & Pacific Co., Inc.1990-02-20
K780190CATHETER STRAP & RUINARY BAY HOLDERBaka Manufacturing Co., Inc.1978-02-21

Legacy Summary#

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FDA Review#

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