The following data is part of a premarket notification filed by Acmi Corporation with the FDA for Plasmaseal Open Forceps, Models 2103pk And 91701pk.
| Device ID | K061975 |
| 510k Number | K061975 |
| Device Name: | PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Terrence E Sullivan |
| Correspondent | Terrence E Sullivan ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-13 |
| Decision Date | 2006-08-10 |
| Summary: | summary |