Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K053120 |
FOIA Releasable 510(k) |
K053120
|
Device Name |
STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES |
Applicant |
EXCELSIOR MEDICAL CORP. |
1923 HECK AVE. |
NEPTUNE,
NJ
07753
|
|
Applicant Contact |
RUBEN MARTINEZ |
Correspondent |
EXCELSIOR MEDICAL CORP. |
1923 HECK AVE. |
NEPTUNE,
NJ
07753
|
|
Correspondent Contact |
RUBEN MARTINEZ |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 11/07/2005 |
Decision Date | 12/09/2005 |
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
|
|
|