The following data is part of a premarket notification filed by Rita Medical Systems, Inc. with the FDA for Omnipicc P.i..
| Device ID | K062579 |
| 510k Number | K062579 |
| Device Name: | OMNIPICC P.I. |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | RITA MEDICAL SYSTEMS, INC. ONE HORIZON WAY Manchester, GA 31816 |
| Contact | David Smith |
| Correspondent | David Smith RITA MEDICAL SYSTEMS, INC. ONE HORIZON WAY Manchester, GA 31816 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-31 |
| Decision Date | 2006-11-28 |
| Summary: | summary |