Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K912877 |
Device Name |
PROFUSE INFUSION SYSTEM |
Applicant |
LAKE REGION MFG., INC. |
340 LAKE HAZELTINE DR. |
CHASKA,
MN
55318
|
|
Applicant Contact |
PAUL KOHL |
Correspondent |
LAKE REGION MFG., INC. |
340 LAKE HAZELTINE DR. |
CHASKA,
MN
55318
|
|
Correspondent Contact |
PAUL KOHL |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 07/01/1991 |
Decision Date | 09/23/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|