Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K962938 |
Device Name |
EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE) |
Applicant |
EXCELSIOR MEDICAL CORP. |
P.O. BOX 299 |
LONG BRANCH,
NJ
07740 -0299
|
|
Applicant Contact |
DAVID LUMIA |
Correspondent |
EXCELSIOR MEDICAL CORP. |
P.O. BOX 299 |
LONG BRANCH,
NJ
07740 -0299
|
|
Correspondent Contact |
DAVID LUMIA |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 07/29/1996 |
Decision Date | 10/25/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|