Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K003977 |
Device Name |
DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET |
Applicant |
DISETRONIC MEDICAL SYSTEMS AG |
5151 PROGRAM AVE. |
ST. PAUL,
MN
55112 -1014
|
|
Applicant Contact |
DAVID E CHADWICK |
Correspondent |
DISETRONIC MEDICAL SYSTEMS AG |
5151 PROGRAM AVE. |
ST. PAUL,
MN
55112 -1014
|
|
Correspondent Contact |
DAVID E CHADWICK |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 12/22/2000 |
Decision Date | 02/15/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|