The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Blaise-rathael Voice Prosthesis.
| Device ID | K832852 |
| 510k Number | K832852 |
| Device Name: | BLAISE-RATHAEL VOICE PROSTHESIS |
| Classification | Prosthesis, Laryngeal (taub) |
| Applicant | RICHARDS MEDICAL CO., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EWL |
| CFR Regulation Number | 874.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-16 |
| Decision Date | 1983-09-29 |