Device Classification Name |
heparin, vascular access flush
|
510(k) Number |
K092491 |
Device Name |
MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES |
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 | 08/13/2009 |
Decision Date | 02/03/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|
|
|