Device Classification Name |
pump, infusion
|
510(k) Number |
K862927 |
Device Name |
CADD-1, MODEL 5100 HF |
Applicant |
DELTEC SYSTEMS, INC. |
1265 GREY FOX RD. |
ST PAUL,
MN
55112
|
|
Applicant Contact |
JAMES E LESLIE |
Correspondent |
DELTEC SYSTEMS, INC. |
1265 GREY FOX RD. |
ST PAUL,
MN
55112
|
|
Correspondent Contact |
JAMES E LESLIE |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 08/01/1986 |
Decision Date | 08/27/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|