The following data is part of a premarket notification filed by Helix Medical, Inc. with the FDA for Blom-singer Low Pressure Voice Prosthesis,p.i.d.s..
| Device ID | K930105 |
| 510k Number | K930105 |
| Device Name: | BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S. |
| Classification | Prosthesis, Laryngeal (taub) |
| Applicant | HELIX MEDICAL, INC. 210 SANTA BARBERA ST. Santa Barbera, CA 93101 |
| Contact | Christine Emanuel |
| Correspondent | Christine Emanuel HELIX MEDICAL, INC. 210 SANTA BARBERA ST. Santa Barbera, CA 93101 |
| Product Code | EWL |
| CFR Regulation Number | 874.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-11 |
| Decision Date | 1993-05-17 |