The following data is part of a premarket notification filed by Bioderm, Inc. with the FDA for Bioderm Eid Male External Incontinence Device.
| Device ID | K963950 |
| 510k Number | K963950 |
| Device Name: | BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE |
| Classification | Device, Paste-on For Incontinence, Sterile |
| Applicant | BIODERM, INC. 29 AINSWORTH AVE. East Brunswick, NJ 08816 |
| Contact | Eric Flam |
| Correspondent | Eric Flam BIODERM, INC. 29 AINSWORTH AVE. East Brunswick, NJ 08816 |
| Product Code | EXI |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-02 |
| Decision Date | 1997-01-10 |
| Summary: | summary |