The following data is part of a premarket notification filed by Gyrus Medical, Inc. with the FDA for Pk Zip Wing Cutting Dissector.
| Device ID | K023493 |
| 510k Number | K023493 |
| Device Name: | PK ZIP WING CUTTING DISSECTOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GYRUS MEDICAL, INC. 6655 WEDGWOOD RD. Minneapolis, MN 55311 -3602 |
| Contact | Frederick G Mades |
| Correspondent | Frederick G Mades GYRUS MEDICAL, INC. 6655 WEDGWOOD RD. Minneapolis, MN 55311 -3602 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-18 |
| Decision Date | 2002-11-13 |
| Summary: | summary |