Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K760111 |
Device Name |
FILTER, I.V., WITH FLASH BULB (#4701) |
Applicant |
JELCO LABORATORIES |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
JELCO LABORATORIES |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 06/24/1976 |
Decision Date | 07/16/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|