The following data is part of a premarket notification filed by Covidien Lp with the FDA for Valleylab Suction Coagulator, Model E3305.
| Device ID | K091223 |
| 510k Number | K091223 |
| Device Name: | VALLEYLAB SUCTION COAGULATOR, MODEL E3305 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | COVIDIEN LP 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Philip Ake |
| Correspondent | Philip Ake COVIDIEN LP 5920 LONGBOW DR. Boulder, CO 80301 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-27 |
| Decision Date | 2009-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889942016235 | K091223 | 000 |
| 10884521039094 | K091223 | 000 |
| 10884521039070 | K091223 | 000 |
| 10884521039100 | K091223 | 000 |
| 10884521039087 | K091223 | 000 |
| 20884521039091 | K091223 | 000 |
| 20884521039077 | K091223 | 000 |