The following data is part of a premarket notification filed by Gyrus-acmi L.p. with the FDA for Pks Omni Instrument.
| Device ID | K081766 |
| 510k Number | K081766 |
| Device Name: | PKS OMNI INSTRUMENT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GYRUS-ACMI L.P. 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Lorraine Calzetta |
| Correspondent | Lorraine Calzetta GYRUS-ACMI L.P. 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-20 |
| Decision Date | 2008-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925011311 | K081766 | 000 |
| 00821925011328 | K081766 | 000 |
| 00821925011304 | K081766 | 000 |
| 00821925011298 | K081766 | 000 |