The following data is part of a premarket notification filed by Hays & Meade, Inc. with the FDA for H&m Anti-snoring Device.
Device ID | K882303 |
510k Number | K882303 |
Device Name: | H&M ANTI-SNORING DEVICE |
Classification | Device, Anti-snoring |
Applicant | HAYS & MEADE, INC. P.O. BOX 25565 Albuquerque, NM 87125 |
Contact | Robert N Singer |
Correspondent | Robert N Singer HAYS & MEADE, INC. P.O. BOX 25565 Albuquerque, NM 87125 |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-03 |
Decision Date | 1989-04-14 |