Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K852140 |
Device Name |
NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS) |
Applicant |
NORTH AMERICAN INSTRUMENT CORP. |
HUDSON FALLS,
NY
12839
|
|
Applicant Contact |
PHILLIP H MORSE |
Correspondent |
NORTH AMERICAN INSTRUMENT CORP. |
HUDSON FALLS,
NY
12839
|
|
Correspondent Contact |
PHILLIP H MORSE |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 05/16/1985 |
Decision Date | 05/30/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|