510(k) K963950
- Device
- BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE
- Applicant
- BIODERM, INC.
- 510(k) number
- K963950
- Product code
- EXI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-01-10
- Date received
- 1996-10-02
- Regulation
- 876.5250
- Classification name
- Device, Paste-on For Incontinence, 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
- ERIC FLAM
- Address
- 29 Ainsworth Ave. East Burnswick NJ US 08816 08816
FDA Registration Numbers#
- 3012421607
- 3014421917
- 3011707784
- 3016884033
- 3018116884
- 1417592
- 2020282
- 3006673317
- 3012568936
- 3015058854
- 3016761372
- 3010187802
- 3007007790
- 3016171914
- 3014637079
- 3005105203
- 3009104075
- 3015337348
Source Documents#
Other 510(k) Records For Product Code EXI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K971499 | FEMALE EXTERNAL URINARY COLLECTION POUCH | Mediquest, Inc. | 1997-08-28 |
| K970443 | HOLLISTER RETRACTED PENIS POUCH | Hollister, Inc. | 1997-02-25 |
| K931277 | HOLLISTER PREMIUM URINE COLLECTOR | Hollister, Inc. | 1993-06-23 |
| K924755 | CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION | Convatec, A Division of E.R. Squibb & Sons | 1993-06-22 |
| K915246 | CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH) | Coloplast A/S | 1992-02-05 |
| K915616 | URIHESIVE STRIP | Convatec, A Division of E.R. Squibb & Sons | 1992-01-23 |
Legacy Summary#
summary
FDA Review#
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