The following data is part of a premarket notification filed by Helix Medical, Inc. with the FDA for Blom-singer Indwelling 2000 Voice Prosthesis.
| Device ID | K991587 |
| 510k Number | K991587 |
| Device Name: | BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS |
| Classification | Prosthesis, Laryngeal (taub) |
| Applicant | HELIX MEDICAL, INC. 1110 MARK AVE. Carpinteria, CA 93013 |
| Contact | Cynthia Anderson |
| Correspondent | Cynthia Anderson HELIX MEDICAL, INC. 1110 MARK AVE. Carpinteria, CA 93013 |
| Product Code | EWL |
| CFR Regulation Number | 874.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-07 |
| Decision Date | 1999-06-25 |
| Summary: | summary |