The following data is part of a premarket notification filed by Gyrus Acmi Inc with the FDA for Pk Aim.
| Device ID | K152219 |
| 510k Number | K152219 |
| Device Name: | PK AIM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GYRUS ACMI INC 136 TURNPIKE ROAD Southborough, MA 01772 |
| Contact | Neil Kelly |
| Correspondent | Neil Kelly GYRUS ACMI INC 136 TURNPIKE ROAD 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 | 2015-08-07 |
| Decision Date | 2015-12-17 |
| Summary: | summary |