Device Classification Name |
saline, vascular access flush
|
510(k) Number |
K111034 |
Device Name |
AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE |
Applicant |
AM USA |
5209 LINDBAR DRIVE |
SUITE 640 |
NASHVILLE,
TN
37167
|
|
Applicant Contact |
KAREN THOMISON |
Correspondent |
AM USA |
5209 LINDBAR DRIVE |
SUITE 640 |
NASHVILLE,
TN
37167
|
|
Correspondent Contact |
KAREN THOMISON |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 04/13/2011 |
Decision Date | 07/14/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|