The following data is part of a premarket notification filed by Gyrus Medical, Inc. with the FDA for Gyrus Plasma Skin Resurfacing System.
| Device ID | K023111 |
| 510k Number | K023111 |
| Device Name: | GYRUS PLASMA SKIN RESURFACING SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GYRUS MEDICAL, INC. 6655 WEDGWOOD RD. SUITE 105 Maple Grove, MN 55311 -3602 |
| Contact | Mark Jensen |
| Correspondent | Mark Jensen GYRUS MEDICAL, INC. 6655 WEDGWOOD RD. SUITE 105 Maple Grove, MN 55311 -3602 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-19 |
| Decision Date | 2003-03-13 |
| Summary: | summary |