Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K974013 |
Device Name |
EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE |
Applicant |
SIMS DELTEC, INC. |
1265 GREY FOX RD. |
ST. PAUL,
MN
55112
|
|
Applicant Contact |
EDWARD W NUMAINVILLE |
Correspondent |
SIMS DELTEC, INC. |
1265 GREY FOX RD. |
ST. PAUL,
MN
55112
|
|
Correspondent Contact |
EDWARD W NUMAINVILLE |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 10/22/1997 |
Decision Date | 12/17/1997 |
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
|
|
|