Device Classification Name |
Arterial Blood Sampling Kit
|
510(k) Number |
K914778 |
Device Name |
NEOLINE(TM) |
Applicant |
MARTECH MEDICAL PRODUCTS, INC. |
43223 BUSINESS PARK DR. |
TEMECULA,
CA
92590
|
|
Applicant Contact |
MICHAEL D MARTELL |
Correspondent |
MARTECH MEDICAL PRODUCTS, INC. |
43223 BUSINESS PARK DR. |
TEMECULA,
CA
92590
|
|
Correspondent Contact |
MICHAEL D MARTELL |
Regulation Number | 868.1100
|
Classification Product Code |
|
Date Received | 10/23/1991 |
Decision Date | 09/16/1992 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|