The following data is part of a premarket notification filed by Acmi Corporation with the FDA for Bicap Coag Bipolar Laparoscopy Probe, Model 006908-910.
| Device ID | K012018 |
| 510k Number | K012018 |
| Device Name: | BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Frank J Fucile |
| Correspondent | Frank J Fucile ACMI CORPORATION 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 | 2001-06-28 |
| Decision Date | 2002-07-16 |
| Summary: | summary |