Device Classification Name |
Arterial Blood Sampling Kit
|
510(k) Number |
K945485 |
Device Name |
ABG NEEDLE PROTECTION |
Applicant |
DEVON INDUSTRIES, INC. |
9530 DESOTO AVE. |
CHATSWORTH,
CA
91311 -5084
|
|
Applicant Contact |
GEORGE AUSTRIA |
Correspondent |
DEVON INDUSTRIES, INC. |
9530 DESOTO AVE. |
CHATSWORTH,
CA
91311 -5084
|
|
Correspondent Contact |
GEORGE AUSTRIA |
Regulation Number | 868.1100
|
Classification Product Code |
|
Date Received | 11/08/1994 |
Decision Date | 11/29/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|