Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K011888 |
Device Name |
PRESSURE ACTIVATED CHECK VALVE |
Applicant |
CHURCHILL MEDICAL SYSTEMS, INC. |
87 VENTURE DR. |
DOVER,
NH
03820
|
|
Applicant Contact |
KEITH PALUCH |
Correspondent |
CHURCHILL MEDICAL SYSTEMS, INC. |
87 VENTURE DR. |
DOVER,
NH
03820
|
|
Correspondent Contact |
KEITH PALUCH |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 06/18/2001 |
Decision Date | 09/10/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|