The following data is part of a premarket notification filed by Medisiss with the FDA for Medississ Reprocessedent Ablation Wands (coblators), Model#eic8872-01.
| Device ID | K100543 |
| 510k Number | K100543 |
| Device Name: | MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEDISISS 2747 SW 6TH STREET Redmond, OR 97756 |
| Contact | Brandi James |
| Correspondent | Brandi James MEDISISS 2747 SW 6TH STREET Redmond, OR 97756 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-25 |
| Decision Date | 2010-07-23 |
| Summary: | summary |