Device Classification Name |
introducer, catheter
|
510(k) Number |
K983039 |
Device Name |
EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR, EMCEE INFUSION INTRODUCER SHEATH SET, EMCEE INF |
Applicant |
SCHNEIDER/NAMIC |
PRUYN'S ISLAND |
GLENS FALLS,
NY
12801
|
|
Applicant Contact |
KARIN L SMITH |
Correspondent |
SCHNEIDER/NAMIC |
PRUYN'S ISLAND |
GLENS FALLS,
NY
12801
|
|
Correspondent Contact |
KARIN L SMITH |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 08/31/1998 |
Decision Date | 05/07/1999 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|