The following data is part of a premarket notification filed by Electromedics Co. Ltd. with the FDA for Fas-clean Electrosurgical Coated Active Blade.
| Device ID | K073616 |
| 510k Number | K073616 |
| Device Name: | FAS-CLEAN ELECTROSURGICAL COATED ACTIVE BLADE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ELECTROMEDICS CO. LTD. 55 ANDERSON AVENUE Moonachie, NJ 07074 |
| Contact | John Scholz |
| Correspondent | John Scholz ELECTROMEDICS CO. LTD. 55 ANDERSON AVENUE Moonachie, NJ 07074 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-26 |
| Decision Date | 2008-07-23 |
| Summary: | summary |