Device Classification Name |
pump, infusion, elastomeric
|
510(k) Number |
K042122 |
Device Name |
SMARTINFUSER PAINPUMP |
Applicant |
PRECISE MEDICAL PRODUCTS |
DORA ST. (INDUSTRIAL AREA) |
SHLOMI,
IL
22832
|
|
Applicant Contact |
OFER SHAI |
Correspondent |
PRECISE MEDICAL PRODUCTS |
DORA ST. (INDUSTRIAL AREA) |
SHLOMI,
IL
22832
|
|
Correspondent Contact |
OFER SHAI |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 08/06/2004 |
Decision Date | 09/22/2004 |
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
|
|
|