The following data is part of a premarket notification filed by Universal Prosthetics, Inc. with the FDA for Northwestern Voice Restoration Kit.
| Device ID | K811428 |
| 510k Number | K811428 |
| Device Name: | NORTHWESTERN VOICE RESTORATION KIT |
| Classification | Tube, Laryngectomy |
| Applicant | UNIVERSAL PROSTHETICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KAC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-22 |
| Decision Date | 1981-06-16 |