The following data is part of a premarket notification filed by Helix Medical, Inc. with the FDA for Blom-singer(r) Silicone Laryngectomy Tube.
| Device ID | K897005 |
| 510k Number | K897005 |
| Device Name: | BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE |
| Classification | Tube Tracheostomy And Tube Cuff |
| 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 | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-18 |
| Decision Date | 1990-03-16 |