The following data is part of a premarket notification filed by Silent Knights Ventures, Inc. with the FDA for The Silencer.
| Device ID | K954530 |
| 510k Number | K954530 |
| Device Name: | THE SILENCER |
| Classification | Device, Anti-snoring |
| Applicant | SILENT KNIGHTS VENTURES, INC. 1050-1188 WEST GEORGIA ST. Vancouver, CA V6e 4a2 |
| Contact | L. Wayne Halstrom |
| Correspondent | L. Wayne Halstrom SILENT KNIGHTS VENTURES, INC. 1050-1188 WEST GEORGIA ST. Vancouver, CA V6e 4a2 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-29 |
| Decision Date | 1995-10-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810002220258 | K954530 | 000 |