The following data is part of a premarket notification filed by Dacomed Corp. with the FDA for Dacomed Corp. Eska-herrman Voice Prosthesis.
| Device ID | K854118 |
| 510k Number | K854118 |
| Device Name: | DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS |
| Classification | Prosthesis, Laryngeal (taub) |
| Applicant | DACOMED CORP. 1701 E. 79TH ST., STE. 17 Minneapolis, MN 55425 |
| Contact | Michael W Walsh |
| Correspondent | Michael W Walsh DACOMED CORP. 1701 E. 79TH ST., STE. 17 Minneapolis, MN 55425 |
| Product Code | EWL |
| CFR Regulation Number | 874.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-09 |
| Decision Date | 1986-03-17 |