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510(k) K950784

Device
DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM
Applicant
ADVANCED BIORESEARCH ASSOC.
510(k) number
K950784
Product code
EYQ  
Decision
Substantially Equivalent (SESE)
Decision date
1995-05-03
Date received
1995-02-21
Regulation
876.5920
Classification name
Garment, Protective, For Incontinence
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
STEVE REITZLER
Address
1700 Rockville Pike, Suite 450 Rockville MD US 20852 20852

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EYQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K932310KIT PAK INCONTINENT SKIN CARE KITKit Pak, Inc.1994-06-01
K903342DEODORIZING AND SOUND MUFFLING ANAL PADBiological Resistance, Inc.1990-10-23
K891686LIB SYSTEM, BABY/ADULT DIAPERIntera Corp.1989-05-31
K885185INTERA SHIELD AND INTERA UNDERGARMENTIntera Corp.1989-02-08
K883894DRIPRIDE PROVIDE SLIMWeyerhaeuser Co.1989-01-30
K883895DRIPRIDE ULTRA INCONTINENT PADWeyerhaeuser Co.1989-01-30
K883787REUSABLE ADULT INCONTINENT DIAPERIntera Corp.1988-11-07
K882418DRY COMFORT UNDERGARMENTHealth Tec, Inc.1988-09-29
K880454AT EASE STRESS PADHospital Specialty Co.1988-06-16
K880455AT EASE ADULT DIAPERHospital Specialty Co.1988-04-14
K880338CHICOPEE ADULT INCONTINENCE SHIELDSChicopee, Inc.1988-03-31
K872059DRIPRIDE PROVIDE ULTRAWeyerhaeuser Co.1988-03-16
K873036ATTENDS INCONTINENT BRIEFProcter & Gamble Mfg. Co.1988-01-19
K862877MALE URINARY STRESS PAD*Convatec, A Division of E.R. Squibb & Sons1986-11-19
K862878FREE & ACTIVE(TM) ABSORBENT PADSConvatec, A Division of E.R. Squibb & Sons1986-11-19

Legacy Summary#

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FDA Review#

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