Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K031361 |
Device Name |
CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP |
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 | 880.5440
|
Classification Product Code |
|
Date Received | 04/30/2003 |
Decision Date | 05/23/2003 |
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
|
|
|