The following data is part of a premarket notification filed by Encision, Inc. with the FDA for Aem Disposable Electrodes,model Eso300 Series.
| Device ID | K091074 |
| 510k Number | K091074 |
| Device Name: | AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ENCISION, INC. 6797 WINCHESTER CIR. Boulder, CO 80301 |
| Contact | Judith King |
| Correspondent | Jay Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-04-14 |
| Decision Date | 2009-08-17 |
| Summary: | summary |