The following data is part of a premarket notification filed by Surface Mount Technology, Inc. with the FDA for Sustained Phonation.
| Device ID | K962961 |
| 510k Number | K962961 |
| Device Name: | SUSTAINED PHONATION |
| Classification | Device, Anti-stammering |
| Applicant | SURFACE MOUNT TECHNOLOGY, INC. 2181 PINNACLE PKWY. Twinsburg, OH 44087 |
| Contact | Roger Zimmerman |
| Correspondent | Roger Zimmerman SURFACE MOUNT TECHNOLOGY, INC. 2181 PINNACLE PKWY. Twinsburg, OH 44087 |
| Product Code | KTH |
| CFR Regulation Number | 874.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-30 |
| Decision Date | 1996-09-09 |