Device Classification Name |
Saline, Vascular Access Flush
|
510(k) Number |
K121262 |
Device Name |
MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY |
Applicant |
MEDEFIL, INC. |
250 WINDY POINT DR. |
GLENDALE HEIGHTS,
IL
60139
|
|
Applicant Contact |
PRADEEP AGGARWAL |
Correspondent |
MEDEFIL, INC. |
250 WINDY POINT DR. |
GLENDALE HEIGHTS,
IL
60139
|
|
Correspondent Contact |
PRADEEP AGGARWAL |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 04/26/2012 |
Decision Date | 09/20/2012 |
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
|
|
|