Device Classification Name |
Heparin, Vascular Access Flush
|
510(k) Number |
K061497 |
Device Name |
SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML |
Applicant |
EXCELSIOR MEDICAL CORP. |
1933 HECK AVE |
NEPTUNE,
NJ
07753
|
|
Applicant Contact |
JOHN TALARICO |
Correspondent |
EXCELSIOR MEDICAL CORP. |
1933 HECK AVE |
NEPTUNE,
NJ
07753
|
|
Correspondent Contact |
JOHN TALARICO |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 05/31/2006 |
Decision Date | 02/23/2007 |
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 |
No
|
Recalls |
CDRH Recalls
|
|
|