Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K941244 |
Device Name |
SAFELINE SYSTEM TURN LOCK CANNULA |
Applicant |
MCGAW, INC. |
2525 MCGAW AVE. |
IRVINE,
CA
92714 -5895
|
|
Applicant Contact |
JOHN G D'ANGELO |
Correspondent |
MCGAW, INC. |
2525 MCGAW AVE. |
IRVINE,
CA
92714 -5895
|
|
Correspondent Contact |
JOHN G D'ANGELO |
Regulation Number | 880.5440
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/15/1994 |
Decision Date | 11/29/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|