Device Classification Name |
valve, non-rebreathing
|
510(k) Number |
K132143 |
Device Name |
EXHALATION VALVE |
Applicant |
INTERSURGICAL INCORPORATED |
417 ELECTRONICS PARKWAY |
LIVERPOOL,
NY
13088
|
|
Applicant Contact |
MICHAEL ZALEWSKI |
Correspondent |
INTERSURGICAL INCORPORATED |
417 ELECTRONICS PARKWAY |
LIVERPOOL,
NY
13088
|
|
Correspondent Contact |
MICHAEL ZALEWSKI |
Regulation Number | 868.5870
|
Classification Product Code |
|
Date Received | 07/11/2013 |
Decision Date | 06/04/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|