FDA.reportPublic FDA data

510(k) K903715

Device
CONDOM SEAL
Applicant
MARK SULLIVAN, M.D., P.C.
510(k) number
K903715
Product code
EXJ  
Decision
Substantially Equivalent (SESE)
Decision date
1991-01-23
Date received
1990-08-14
Regulation
876.5250
Classification name
Device, Incontinence, Urosheath Type, Sterile
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MARK SULLIVAN
Address
26732 Crown Valley Pkwy. Suite 111 Mission Viejo CA US 92691 92691

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EXJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K970465BOUSER'S URINALGeneral Polymers1997-12-18
K972100VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)Advanced Care Medical Products1997-07-31
K970966COMFORT CATH CHOICE MALE EXTERNAL CATHETERSierra Laboratories, Inc.1997-04-22
K963265PROSYS SAMEC LAConvatec, A Division of E.R. Squibb & Sons1996-10-25
K962900SELF RETAINING MALE EXTERNAL URINARY CATHETERHollister, Inc.1996-09-16
K962413COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETERSierra Laboratories, Inc.1996-07-15
K962384COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETERSierra Laboratories, Inc.1996-07-15
K952082ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETERRochester Medical Corp.1995-07-18
K945628CLEAR ADVANTAGE IIMentor Corp.1995-07-06
K951530PROSYS URIHESIVE SYSTEM LAConvatec, A Division of E.R. Squibb & Sons1995-05-12
K950690PROSYS URIHESICE SYSTEM NLConvatec, A Division of E.R. Squibb & Sons1995-03-23
K942941CONQUEST MALE CONTINENCE SYSTEMConvatec, A Bristol-Myers Squibb Co.1995-03-17
K946243CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETERColoplast A/S1995-02-13
K940269HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETERHollister, Inc.1994-06-02
K934266COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETERSierra Laboratories, Inc.1994-04-19

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases