Device Classification Name |
pump, infusion
|
510(k) Number |
K041414 |
Device Name |
CRONO AND CRONO, MODEL 30 |
Applicant |
CANE S.R.L. |
P.O. BOX 7007 |
DEERFIELD,
IL
60015
|
|
Applicant Contact |
DANIEL KAMM |
Correspondent |
CANE S.R.L. |
P.O. BOX 7007 |
DEERFIELD,
IL
60015
|
|
Correspondent Contact |
DANIEL KAMM |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 05/27/2004 |
Decision Date | 07/08/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|