Device Classification Name |
Anesthesia Conduction Kit
|
510(k) Number |
K001587 |
Device Name |
19 GA PLASTIC REINFORCED EPIDURAL CATHETER |
Applicant |
ARROW INTL., INC. |
2400 BERNVILLE RD. |
READING,
PA
19605
|
|
Applicant Contact |
THOMAS D NICKEL |
Correspondent |
ARROW INTL., INC. |
2400 BERNVILLE RD. |
READING,
PA
19605
|
|
Correspondent Contact |
THOMAS D NICKEL |
Regulation Number | 868.5140
|
Classification Product Code |
|
Date Received | 05/23/2000 |
Decision Date | 07/12/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|