The following data is part of a premarket notification filed by Ranir Llc with the FDA for Snore Guard Advance.
Device ID | K102118 |
510k Number | K102118 |
Device Name: | SNORE GUARD ADVANCE |
Classification | Device, Anti-snoring |
Applicant | RANIR LLC 555 THIRTEENTH STREET, NW Washington, DC 20004 |
Contact | Gerard J Prud'homme |
Correspondent | Gerard J Prud'homme RANIR LLC 555 THIRTEENTH STREET, NW Washington, DC 20004 |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-07-28 |
Decision Date | 2010-09-08 |
Summary: | summary |