Device Classification Name |
Anesthesia Conduction Kit
|
510(k) Number |
K030937 |
Device Name |
STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK |
Applicant |
ARROW INTERNATIONAL, INC. |
2400 BERNVILLE RD. |
READING,
PA
19605 -9607
|
|
Applicant Contact |
BRANDON EPTING |
Correspondent |
ARROW INTERNATIONAL, INC. |
2400 BERNVILLE RD. |
READING,
PA
19605 -9607
|
|
Correspondent Contact |
BRANDON EPTING |
Regulation Number | 868.5140
|
Classification Product Code |
|
Date Received | 03/25/2003 |
Decision Date | 04/23/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|