Device Classification Name |
Dilator, Nasal
|
510(k) Number |
K181219 |
Device Name |
OptiPillows EPAP Mask |
Applicant |
Cpapnea Medical Supply |
10443 N Cave Creek Rd, Suite 110 |
Phoenix,
AZ
85020
|
|
Applicant Contact |
Sal T. Hakim |
Correspondent |
Cpapnea Medical Supply |
10443 N Cave Creek Road, Suite 110 |
Phoenix,
AZ
85020
|
|
Correspondent Contact |
Sal T. Hakim |
Regulation Number | 874.3900
|
Classification Product Code |
|
Date Received | 05/07/2018 |
Decision Date | 08/03/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|