Device Classification Name |
container, i.v.
|
510(k) Number |
K041038 |
Device Name |
CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER |
Applicant |
CHURCHILL MEDICAL SYSTEMS, INC. |
87 VENTURE DR. |
ENTERPRISE PARK |
DOVER,
NH
03820
|
|
Applicant Contact |
KEITH PALUCH |
Correspondent |
CHURCHILL MEDICAL SYSTEMS, INC. |
87 VENTURE DR. |
ENTERPRISE PARK |
DOVER,
NH
03820
|
|
Correspondent Contact |
KEITH PALUCH |
Regulation Number | 880.5025
|
Classification Product Code |
|
Date Received | 04/22/2004 |
Decision Date | 12/21/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|