Device Classification Name |
Pump, Infusion, Enteral
|
510(k) Number |
K981541 |
Device Name |
CLEARSTAR ENTERAL NUTRITION PUMP |
Applicant |
FRANTZ MEDICAL DEVELOPMENT, LTD. |
7740 METRIC DR. |
MENTOR,
OH
44060
|
|
Applicant Contact |
J P HANSON |
Correspondent |
FRANTZ MEDICAL DEVELOPMENT, LTD. |
7740 METRIC DR. |
MENTOR,
OH
44060
|
|
Correspondent Contact |
J P HANSON |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 04/29/1998 |
Decision Date | 08/13/1998 |
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
|
Recalls |
CDRH Recalls
|
|
|