The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Pk Superpulse Sysem Generator Model 744000.
| Device ID | K100816 |
| 510k Number | K100816 |
| Device Name: | PK SUPERPULSE SYSEM GENERATOR MODEL 744000 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Graham A.l. Baillie |
| Correspondent | Graham A.l. Baillie GYRUS ACMI, INC. 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 | 2010-03-23 |
| Decision Date | 2010-07-01 |
| Summary: | summary |