The following data is part of a premarket notification filed by Embassy Dental Laboratory with the FDA for Acrylic Herbst Appliance.
Device ID | K111009 |
510k Number | K111009 |
Device Name: | ACRYLIC HERBST APPLIANCE |
Classification | Device, Anti-snoring |
Applicant | EMBASSY DENTAL LABORATORY 8202 SHERMAN ROAD Chesterland, OH 44026 |
Contact | Karen E Warden, Phd |
Correspondent | Karen E Warden, Phd EMBASSY DENTAL LABORATORY 8202 SHERMAN ROAD Chesterland, OH 44026 |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-04-11 |
Decision Date | 2011-07-22 |
Summary: | summary |