Device Classification Name |
saline, vascular access flush
|
510(k) Number |
K082837 |
Device Name |
STERILE FIELD SALINE PRE-FILLED SYRINGE(S) |
Applicant |
EXCELSIOR MEDICAL CORP. |
1933 HECK AVE. |
NEPTUNE,
NJ
07753
|
|
Applicant Contact |
JOHN LINFANTE |
Correspondent |
EXCELSIOR MEDICAL CORP. |
1933 HECK AVE. |
NEPTUNE,
NJ
07753
|
|
Correspondent Contact |
JOHN LINFANTE |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 09/26/2008 |
Decision Date | 12/18/2008 |
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
|
|
|