The following data is part of a premarket notification filed by Slumber Research, Inc. with the FDA for Silentsleep.
Device ID | K801927 |
510k Number | K801927 |
Device Name: | SILENTSLEEP |
Classification | Mouthpiece, Saliva Ejector |
Applicant | SLUMBER RESEARCH, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DYN |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-08-12 |
Decision Date | 1980-11-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SILENTSLEEP 87816858 not registered Live/Pending |
Helen of Troy Limited 2018-03-01 |
SILENTSLEEP 73342030 not registered Dead/Abandoned |
SCHMIDT, HANS A. 0000-00-00 |