The following data is part of a premarket notification filed by Selane Products, Inc. with the FDA for Atg/sm-osa Appliances.
Device ID | K130130 |
510k Number | K130130 |
Device Name: | ATG/SM-OSA APPLIANCES |
Classification | Device, Jaw Repositioning |
Applicant | SELANE PRODUCTS, INC. 7046 OWL'S NEST TERRACE Bradenton, FL 34203 |
Contact | Carolyn Primus |
Correspondent | Carolyn Primus SELANE PRODUCTS, INC. 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 | 2013-01-17 |
Decision Date | 2013-08-26 |
Summary: | summary |