Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K903809 |
Device Name |
PROTECTED NEEDLE WITH OR WITHOUT IV SET |
Applicant |
KENDALL MCGAW LABORATORIES, INC. |
2525 MCGAW AVE. |
P.O. BOX 19791 |
IRVINE,
CA
92713
|
|
Applicant Contact |
JOHN G D'ANGELO |
Correspondent |
KENDALL MCGAW LABORATORIES, INC. |
2525 MCGAW AVE. |
P.O. BOX 19791 |
IRVINE,
CA
92713
|
|
Correspondent Contact |
JOHN G D'ANGELO |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 08/20/1990 |
Decision Date | 10/03/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|