The following data is part of a premarket notification filed by Ellman Int'l Inc. with the FDA for Ellman International Non-ablative Technique For Surgitron Iec.
| Device ID | K082834 |
| 510k Number | K082834 |
| Device Name: | ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ELLMAN INT'L INC. 3333 ROYAL AVENUE Oceanside, NY 11572 -3625 |
| Contact | Rick Epstein |
| Correspondent | Rick Epstein ELLMAN INT'L INC. 3333 ROYAL AVENUE Oceanside, NY 11572 -3625 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-26 |
| Decision Date | 2009-05-07 |
| Summary: | summary |