The following data is part of a premarket notification filed by American Cystocope Makers, Inc. with the FDA for Acmi Bipolar Hemostatic Electrode.
| Device ID | K803214 |
| 510k Number | K803214 |
| Device Name: | ACMI BIPOLAR HEMOSTATIC ELECTRODE |
| Classification | Electrode, Flexible Suction Coagulator |
| Applicant | AMERICAN CYSTOCOPE MAKERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FEH |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-18 |
| Decision Date | 1981-01-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30653405047029 | K803214 | 000 |
| 30653405047012 | K803214 | 000 |
| 30653405047005 | K803214 | 000 |
| 30653405046992 | K803214 | 000 |
| 30653405046800 | K803214 | 000 |