510(k) K963265
- Device
- PROSYS SAMEC LA
- Applicant
- CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
- 510(k) number
- K963265
- Product code
- EXJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-10-25
- Date received
- 1996-08-20
- Regulation
- 876.5250
- Classification name
- Device, Incontinence, Urosheath Type, 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
- SUSIE MERCHANT
- Address
- 100 Headquarters Park Dr. Skillman NJ US 08558 08558
FDA Registration Numbers#
- 3042277801
- 1423537
- 3008489813
- 2938651
- 3009308092
- 1921846
- 3001650535
- 9613418
- 9612030
- 3005273623
- 3003965134
Source Documents#
Other 510(k) Records For Product Code EXJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K970465 | BOUSER'S URINAL | General Polymers | 1997-12-18 |
| K972100 | VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) | Advanced Care Medical Products | 1997-07-31 |
| K970966 | COMFORT CATH CHOICE MALE EXTERNAL CATHETER | Sierra Laboratories, Inc. | 1997-04-22 |
| K962900 | SELF RETAINING MALE EXTERNAL URINARY CATHETER | Hollister, Inc. | 1996-09-16 |
| K962413 | COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER | Sierra Laboratories, Inc. | 1996-07-15 |
| K962384 | COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER | Sierra Laboratories, Inc. | 1996-07-15 |
| K952082 | ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER | Rochester Medical Corp. | 1995-07-18 |
| K945628 | CLEAR ADVANTAGE II | Mentor Corp. | 1995-07-06 |
| K951530 | PROSYS URIHESIVE SYSTEM LA | Convatec, A Division of E.R. Squibb & Sons | 1995-05-12 |
| K950690 | PROSYS URIHESICE SYSTEM NL | Convatec, A Division of E.R. Squibb & Sons | 1995-03-23 |
| K942941 | CONQUEST MALE CONTINENCE SYSTEM | Convatec, A Bristol-Myers Squibb Co. | 1995-03-17 |
| K946243 | CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER | Coloplast A/S | 1995-02-13 |
| K940269 | HOLLISTER NON-ROLLED SELF-ADHESIVE URINARY EXTERNAL CATHETER | Hollister, Inc. | 1994-06-02 |
| K934266 | COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER | Sierra Laboratories, Inc. | 1994-04-19 |
| K931156 | CONE CATH | Sierra Laboratories, Inc. | 1993-07-01 |
Legacy Summary#
summary
FDA Review#
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