The following data is part of a premarket notification filed by Helix Medical, Inc. with the FDA for Inhealth Blom-singer Indwelling Plug Insert Accessory Device.
| Device ID | K945288 |
| 510k Number | K945288 |
| Device Name: | INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE |
| Classification | Prosthesis, Laryngeal (taub) |
| Applicant | HELIX MEDICAL, INC. 1110 MARK AVE. Carpinteria, CA 93013 |
| Contact | Stephen W Laguette |
| Correspondent | Stephen W Laguette 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 | 1994-10-31 |
| Decision Date | 1994-12-02 |