| Device Classification Name |
Accessories, Pump, Infusion
|
| 510(k) Number |
K030936 |
| Device Name |
RITA CLIPS FOR INFUSION PUMPS |
| Applicant |
| Rita Medical Systems, Inc. |
| 967 N. Shoreline Blvd. |
|
Mountain View,
CA
94043
|
|
| Applicant Contact |
VICKI HACKER |
| Correspondent |
| Underwriters Laboratories, Inc. |
| 1655 Scott Blvd. |
|
Santa Clara,
CA
95050
|
|
| Regulation Number | 880.5725 |
| Classification Product Code |
|
| Date Received | 03/25/2003 |
| Decision Date | 04/01/2003 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
Yes
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|