Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K895367 |
Device Name |
INTRAVENOUS EXTENSION SET |
Applicant |
MEDICAL PRODUCT SPECIALISTS |
16 TECHNOLOGY DRIVE, SUITE |
145 |
IRVINE,
CA
92718
|
|
Applicant Contact |
DAN HYUN |
Correspondent |
MEDICAL PRODUCT SPECIALISTS |
16 TECHNOLOGY DRIVE, SUITE |
145 |
IRVINE,
CA
92718
|
|
Correspondent Contact |
DAN HYUN |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 08/28/1989 |
Decision Date | 10/06/1989 |
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
|
|
|