Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K950284 |
Device Name |
SIMS DELTEC, INC. CATHETER REPLACEMENT CONNECTOR |
Applicant |
SIMS DELTEC, INC. |
1265 GREY FOX RD. |
ST. PAUL,
MN
55112
|
|
Applicant Contact |
LISA J STONE |
Correspondent |
SIMS DELTEC, INC. |
1265 GREY FOX RD. |
ST. PAUL,
MN
55112
|
|
Correspondent Contact |
LISA J STONE |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 01/24/1995 |
Decision Date | 05/23/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|