Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K964918 |
Device Name |
NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS |
Applicant |
CRITICAL DEVICE CORP. |
499 NIBUS ST. |
BREA,
CA
92621
|
|
Applicant Contact |
DAN HYUN |
Correspondent |
CRITICAL DEVICE CORP. |
499 NIBUS ST. |
BREA,
CA
92621
|
|
Correspondent Contact |
DAN HYUN |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 12/09/1996 |
Decision Date | 04/14/1997 |
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
|
|
|