Device Classification Name |
Valve, Non-Rebreathing
|
510(k) Number |
K984481 |
Device Name |
EXHALATION VALVE |
Applicant |
INTERSURGICAL, INC. |
417 ELECTRONICS PKWY. |
LIVERPOOL,
NY
13088
|
|
Applicant Contact |
THOMAS R GUNERMAN |
Correspondent |
INTERSURGICAL, INC. |
417 ELECTRONICS PKWY. |
LIVERPOOL,
NY
13088
|
|
Correspondent Contact |
THOMAS R GUNERMAN |
Regulation Number | 868.5870
|
Classification Product Code |
|
Date Received | 12/16/1998 |
Decision Date | 01/29/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|