Device Classification Name |
Pump, Infusion
|
510(k) Number |
K982838 |
Device Name |
CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400 |
Applicant |
SIMS DELTEC, INC. |
1265 GREY FOX RD. |
ST. PAUL,
MN
55112
|
|
Applicant Contact |
EDWARD W NUMAINVILLE |
Correspondent |
SIMS DELTEC, INC. |
1265 GREY FOX RD. |
ST. PAUL,
MN
55112
|
|
Correspondent Contact |
EDWARD W NUMAINVILLE |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 08/12/1998 |
Decision Date | 11/04/1998 |
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
|
Recalls |
CDRH Recalls
|
|
|