Silk Voice
System, Vocal Cord Medialization
Sofregen Medical, Inc.
The following data is part of a premarket notification filed by Sofregen Medical, Inc. with the FDA for Silk Voice.
Pre-market Notification Details
| Device ID | K180631 |
| 510k Number | K180631 |
| Device Name: | Silk Voice |
| Classification | System, Vocal Cord Medialization |
| Applicant | Sofregen Medical, Inc. 200 Boston Avenue, Suite 1100 Medford, MA 02155 |
| Contact | Anh Hoang |
| Correspondent | Anh Hoang Sofregen Medical, Inc. 200 Boston Avenue, Suite 1100 Medford, MA 02155 |
| Product Code | MIX |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-09 |
| Decision Date | 2018-11-08 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B611SV1001 | K180631 | 000 |
| B611SV20011 | K180631 | 000 |
| B611SV10011 | K180631 | 000 |
| B611SV30012 | K180631 | 000 |
| B611SV3001 | K180631 | 000 |
| B611SV2001 | K180631 | 000 |
| B611SV10021 | K180631 | 000 |
| B611SV1002 | K180631 | 000 |
Trademark Results [Silk Voice]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SILK VOICE 87535935 not registered Live/Pending |
Sofregen Medical Ireland Limited 2017-07-20 |
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