The following data is part of a premarket notification filed by Helix Medical, Llc with the FDA for Blom-singer Dual Valve Indwelling Voice Prosthesis, Models Dv-1600 Series, Dv-2000 Series.
| Device ID | K082206 |
| 510k Number | K082206 |
| Device Name: | BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES |
| Classification | Prosthesis, Laryngeal (taub) |
| Applicant | HELIX MEDICAL, LLC 1110 MARK AVE. Carpinteria, CA 93013 |
| Contact | Cynthia Anderson |
| Correspondent | Cynthia Anderson HELIX MEDICAL, LLC 1110 MARK AVE. Carpinteria, CA 93013 |
| Product Code | EWL |
| CFR Regulation Number | 874.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-05 |
| Decision Date | 2008-09-04 |
| Summary: | summary |