510(k) K962604
- Device
- PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING
- Applicant
- CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
- 510(k) number
- K962604
- Product code
- FAQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-07-18
- Date received
- 1996-07-02
- 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
- GEORGE J PRENDERGAST
- Address
- 100 Headquarters Park Dr. Skillman NJ US 08558 08558
FDA Registration Numbers#
- 3013473968
- 3009349165
- 8040459
- 3034669683
- 2320961
- 3031582449
- 1018233
- 3010595915
- 2011171
- 3011020307
- 1061124
- 3014159736
- 9611024
- 3011814545
- 3026331889
- 3010131137
- 9710020
- 3004111573
- 3013513837
- 3014437893
- 3013443304
- 3016884191
- 3010280735
- 3015479927
- 3001124136
- 3033796870
- 3031190571
- 3008496560
- 3005273623
- 1519375
- 3006061749
- 3006673317
- 3003965134
- 3013187142
- 3009104075
- 3005669815
- 1928237
- 1836161
- 9610694
- 3011191255
- 1420054
- 3010700223
- 3005945907
- 3012104670
- 3015058854
- 3007703293
- 3014498861
- 3005327291
- 3013522936
- 3006405073
- 3015176887
- 3008191244
- 3011529314
- 3003824562
- 3004365956
- 3042970965
- 9616991
- 1921846
- 3018503755
- 3015625160
- 3008262278
- 3010339057
- 3013557562
- 3006210673
- 3027315856
- 3015859108
- 3008502431
- 8021995
- 3007007790
- 3011137372
- 3013530901
- 3009746061
- 1417592
- 3007092328
- 1644312
- 3010273861
- 9611590
- 3003814961
- 9616083
Source Documents#
Other 510(k) Records For Product Code FAQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K960217 | CPR URINE BAG | Custom Pack Reliability | 1996-03-28 |
| K955609 | CONVEEN URINE BAG - STERILE | Coloplast Corp. | 1995-12-29 |
| K953767 | PROSYS BEDSIDE DRAINAGE BAG | Convatec, A Division of E.R. Squibb & Sons | 1995-12-20 |
| K953783 | CONVEEN LEG BAG STRAP | Coloplast Corp. | 1995-09-13 |
| K951945 | PROSYS LEG BAG | Convatec, A Division of E.R. Squibb & Sons | 1995-05-25 |
| K945204 | URINE COLLECTOR & ACCESSORIES | Nelmed Corp. | 1994-11-02 |
| K934052 | ALPINE REUSABLE LEG BAGS | Sierra Laboratories, Inc. | 1994-01-07 |
| K931727 | URINARY DRAINAGE BAG CADDY | Neotech Products, Inc. | 1993-07-23 |
| K926035 | BARD LEG BAG HOLDER | C.R. Bard, Inc. | 1992-12-17 |
| K924406 | CONVEEN(R) LEG BAG(500 ML) | Coloplast A/S | 1992-10-30 |
| K903611 | ILC LEG BAG HOLDER | Inman Liebelt Corp. | 1990-10-26 |
| K901219 | EXTERNAL LEG BAG | Orion Life Systems, Inc. | 1990-06-27 |
| K896129 | URINARY LEG BAG | Cypress Medical Products, Ltd. | 1990-04-16 |
| K896728 | 4 SURE URINARY LEG BAG | The Boston & Pacific Co., Inc. | 1990-02-20 |
| K780190 | CATHETER STRAP & RUINARY BAY HOLDER | Baka Manufacturing Co., Inc. | 1978-02-21 |
Legacy Summary#
summary
FDA Review#
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