The following data is part of a premarket notification filed by Rita Medical Systems with the FDA for Habib 4x Laparoscopic.
| Device ID | K062935 |
| 510k Number | K062935 |
| Device Name: | HABIB 4X LAPAROSCOPIC |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | RITA MEDICAL SYSTEMS 46421 LANDING PARKWAY Fremont, CA 94538 |
| Contact | Darrin R Uecker |
| Correspondent | Morten Simon Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-09-28 |
| Decision Date | 2006-10-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H7877001036591 | K062935 | 000 |