Device Classification Name |
Anesthesia Conduction Kit
|
510(k) Number |
K121525 |
Device Name |
PERIFUSE CATHETER |
Applicant |
SMITHS MEDICAL ASD, INC. |
10 BOWMAN DR. |
KEENE,
NH
03431
|
|
Applicant Contact |
CHRISTINE LLOYD |
Correspondent |
SMITHS MEDICAL ASD, INC. |
10 BOWMAN DR. |
KEENE,
NH
03431
|
|
Correspondent Contact |
CHRISTINE LLOYD |
Regulation Number | 868.5140
|
Classification Product Code |
|
Date Received | 05/23/2012 |
Decision Date | 08/02/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|