Device Classification Name |
pump, infusion, insulin
|
510(k) Number |
K020655 |
Device Name |
DELTEC INSULIN INFUSION PUMP AND ACCESSORIES |
Applicant |
DELTEC, INC. |
1265 GREY FOX RD. |
ST. PAUL,
MN
55112
|
|
Applicant Contact |
LISA STONE |
Correspondent |
DELTEC, INC. |
1265 GREY FOX RD. |
ST. PAUL,
MN
55112
|
|
Correspondent Contact |
LISA STONE |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 03/01/2002 |
Decision Date | 08/13/2002 |
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
|
|
|