The following data is part of a premarket notification filed by Exmoor Plastics Ltd. with the FDA for Singh Speech System (series 'sss').
| Device ID | K912486 |
| 510k Number | K912486 |
| Device Name: | SINGH SPEECH SYSTEM (SERIES 'SSS') |
| Classification | Prosthesis, Laryngeal (taub) |
| Applicant | EXMOOR PLASTICS LTD. LISIEUX WAY Taunton, Somerset, GB Ta1 2lb |
| Contact | Brian East |
| Correspondent | Brian East EXMOOR PLASTICS LTD. LISIEUX WAY Taunton, Somerset, GB Ta1 2lb |
| Product Code | EWL |
| CFR Regulation Number | 874.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-04 |
| Decision Date | 1992-09-04 |