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 |