Device Classification Name |
filter, infusion line
|
510(k) Number |
K974661 |
Device Name |
0.2 U BACTERIAL FILTER |
Applicant |
SIMS DELTEC, INC. |
1265 GREY FOX RD. |
ST. PAUL,
MN
55112
|
|
Applicant Contact |
LISA STONE |
Correspondent |
SIMS DELTEC, INC. |
1265 GREY FOX RD. |
ST. PAUL,
MN
55112
|
|
Correspondent Contact |
LISA STONE |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 12/15/1997 |
Decision Date | 02/11/1998 |
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
|
|
|