The following data is part of a premarket notification filed by Acmi Corporation with the FDA for Acmi Vista Ctr Bipolar Loop Electrode.
| Device ID | K031001 |
| 510k Number | K031001 |
| Device Name: | ACMI VISTA CTR BIPOLAR LOOP ELECTRODE |
| Classification | Electrode, Electrosurgical, Active, Urological |
| Applicant | ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Gabriel J Muraca |
| Correspondent | Gabriel J Muraca ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | FAS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-31 |
| Decision Date | 2003-05-21 |
| Summary: | summary |