Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K882503 |
Device Name |
30 IV EXTENSION SET W/TWO MALE LUER LOCKS |
Applicant |
CHURCHILL MEDICAL SYSTEMS, INC. |
905 SHEEHY DR. |
HORSHAM,
PA
19044
|
|
Applicant Contact |
JOEL A MARCUS |
Correspondent |
CHURCHILL MEDICAL SYSTEMS, INC. |
905 SHEEHY DR. |
HORSHAM,
PA
19044
|
|
Correspondent Contact |
JOEL A MARCUS |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 06/17/1988 |
Decision Date | 08/25/1988 |
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
|
|
|