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 |