The following data is part of a premarket notification filed by Eder Instrument Co, Inc. with the FDA for Bipolar Suction Electrode.
| Device ID | K843498 |
| 510k Number | K843498 |
| Device Name: | BIPOLAR SUCTION ELECTRODE |
| Classification | Motor, Surgical Instrument, Pneumatic Powered |
| Applicant | EDER INSTRUMENT CO, INC. 735 NORTH WATER ST. SUITE 1102 Milwaukee, Wi 53202, 53202 |
| Contact | Daniel D Fetterley |
| Correspondent | Daniel D Fetterley EDER INSTRUMENT CO, INC. 735 NORTH WATER ST. SUITE 1102 Milwaukee, Wi 53202, 53202 |
| Product Code | GET |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-06 |
| Decision Date | 1984-12-14 |