The following data is part of a premarket notification filed by Selane Products, Inc. with the FDA for Sml-osa2 Appliances.
Device ID | K162816 |
510k Number | K162816 |
Device Name: | SML-OSA2 Appliances |
Classification | Device, Jaw Repositioning |
Applicant | SELANE PRODUCTS, INC. 9129 LURLINE AVENUE Chatsworth, CA 91311 |
Contact | John Christian |
Correspondent | Carolyn M. Primus PRIMUS CONSULTING 7046 OWL'S NEST TERRACE Bradenton, FL 34203 |
Product Code | LQZ |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-10-06 |
Decision Date | 2017-07-27 |
Summary: | summary |