Device Classification Name |
Pillow, Cervical (For Mild Sleep Apnea)
|
510(k) Number |
K023010 |
Device Name |
SNIFF POSITION PILLOWS/POPITZ PILLOWS |
Applicant |
AEOLUS INTERNATIONAL CORPORATION |
64 INDIAN COVE RD. |
MARION,
MA
02738 -2113
|
|
Applicant Contact |
MICHAEL D POPITZ |
Correspondent |
AEOLUS INTERNATIONAL CORPORATION |
64 INDIAN COVE RD. |
MARION,
MA
02738 -2113
|
|
Correspondent Contact |
MICHAEL D POPITZ |
Regulation Number | 872.5570
|
Classification Product Code |
|
Date Received | 09/09/2002 |
Decision Date | 10/01/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Ear Nose & Throat
|
Statement |
Statement
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|