The following data is part of a premarket notification filed by Porex Surgical, Inc. with the FDA for Porex Electrosurgery Needle.
| Device ID | K052297 |
| 510k Number | K052297 |
| Device Name: | POREX ELECTROSURGERY NEEDLE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | POREX SURGICAL, INC. 15 DART RD. Newnan, GA 30265 |
| Contact | Eric V Hohenstein |
| Correspondent | Eric V Hohenstein POREX SURGICAL, INC. 15 DART RD. Newnan, GA 30265 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-23 |
| Decision Date | 2006-03-28 |
| Summary: | summary |