Device Classification Name |
catheter, conduction, anesthetic
|
510(k) Number |
K050557 |
Device Name |
AMT NANOCATH |
Applicant |
AMERICAN MEDICAL TECHNOLOGIES, INC. |
1211 WEST 13TH ST. |
RIVIERA BEACH,
FL
33404
|
|
Applicant Contact |
MICHAEL RENICK |
Correspondent |
AMERICAN MEDICAL TECHNOLOGIES, INC. |
1211 WEST 13TH ST. |
RIVIERA BEACH,
FL
33404
|
|
Correspondent Contact |
MICHAEL RENICK |
Regulation Number | 868.5120
|
Classification Product Code |
|
Date Received | 03/03/2005 |
Decision Date | 05/27/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|