Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K082009 |
Device Name |
HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS |
Applicant |
HSINER CO., LTD. |
29201 VIA NORTE |
TEMECULA,
CA
92591
|
|
Applicant Contact |
TOM SHANKS |
Correspondent |
HSINER CO., LTD. |
29201 VIA NORTE |
TEMECULA,
CA
92591
|
|
Correspondent Contact |
TOM SHANKS |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 07/23/2008 |
Decision Date | 08/22/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|