Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K961513 |
Device Name |
PROCATH LOCKING PEEL-AWAY INTRODUCER/PEEL-AWAY INTRODUCER SET |
Applicant |
EP MEDSYSTEMS |
334 D-6 COOPER RD. |
BERLIN,
NJ
08009
|
|
Applicant Contact |
JOSEPH C GRIFFIN |
Correspondent |
EP MEDSYSTEMS |
334 D-6 COOPER RD. |
BERLIN,
NJ
08009
|
|
Correspondent Contact |
JOSEPH C GRIFFIN |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 04/19/1996 |
Decision Date | 05/13/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|