Device Classification Name |
syringe, balloon inflation
|
510(k) Number |
K122152 |
Device Name |
OXTI INFLATION DEVICE |
Applicant |
OXTI CORPORATION |
7128 STAFFORDSHIRE STREET |
HOUSTON,
TX
77030
|
|
Applicant Contact |
JOSEPH J CHANG |
Correspondent |
OXTI CORPORATION |
7128 STAFFORDSHIRE STREET |
HOUSTON,
TX
77030
|
|
Correspondent Contact |
JOSEPH J CHANG |
Regulation Number | 870.1650
|
Classification Product Code |
|
Date Received | 07/20/2012 |
Decision Date | 12/14/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|