The following data is part of a premarket notification filed by Dacomed Corp. with the FDA for Dacomed External Male Continence Device.
| Device ID | K885323 |
| 510k Number | K885323 |
| Device Name: | DACOMED EXTERNAL MALE CONTINENCE DEVICE |
| Classification | Clamp, Penile |
| Applicant | DACOMED CORP. 1701 E. 79TH ST., STE. 17 Minneapolis, MN 55425 |
| Contact | Mary M Wilen |
| Correspondent | Mary M Wilen DACOMED CORP. 1701 E. 79TH ST., STE. 17 Minneapolis, MN 55425 |
| Product Code | FHA |
| CFR Regulation Number | 876.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-28 |
| Decision Date | 1989-02-08 |