Device Classification Name |
device, anti-snoring
|
510(k) Number |
K130797 |
Device Name |
LUCO HYBRID OSA APPLIANCE |
Applicant |
LUCO HYBRID OSA APPLIANCE INC. |
1419 BUTTERNUT CREEK ROAD |
KINGSTON, ONTARIO,
CA
K7L 5H6
|
|
Applicant Contact |
KEN LUCO |
Correspondent |
LUCO HYBRID OSA APPLIANCE INC. |
1419 BUTTERNUT CREEK ROAD |
KINGSTON, ONTARIO,
CA
K7L 5H6
|
|
Correspondent Contact |
KEN LUCO |
Regulation Number | 872.5570
|
Classification Product Code |
|
Date Received | 03/22/2013 |
Decision Date | 12/18/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|