Device Classification Name |
Arterial Blood Sampling Kit
|
510(k) Number |
K812338 |
Device Name |
PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY |
Applicant |
TERUMO MEDICAL CORP. |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Correspondent |
TERUMO MEDICAL CORP. |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Regulation Number | 868.1100
|
Classification Product Code |
|
Date Received | 08/18/1981 |
Decision Date | 09/23/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|