Device Classification Name |
Saline, Vascular Access Flush
|
510(k) Number |
K142620 |
Device Name |
0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe |
Applicant |
Excelsior Medical Corporation |
1933 Heck Avenue |
Neptune,
NJ
07553
|
|
Applicant Contact |
John Linfante |
Correspondent |
Excelsior Medical Corporation |
1933 Heck Avenue |
Neptune,
NJ
07553
|
|
Correspondent Contact |
John Linfante |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 09/16/2014 |
Decision Date | 12/12/2014 |
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
|
|
|