Device Classification Name |
Catheter, Conduction, Anesthetic
|
510(k) Number |
K110814 |
Device Name |
AMBIT TUNNELER |
Applicant |
SUMMIT MEDICAL PRODUCTS, INC |
2480 SOUTH MAIN STREET |
#212 |
SALT LAKE CITY,
UT
84118
|
|
Applicant Contact |
MARKO V AMEN |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
NED DEVINE |
Regulation Number | 868.5120
|
Classification Product Code |
|
Date Received | 03/24/2011 |
Decision Date | 04/08/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|