The following data is part of a premarket notification filed by Ellman Intl., Inc. with the FDA for Surgitron Iec Ii.
| Device ID | K001253 |
| 510k Number | K001253 |
| Device Name: | SURGITRON IEC II |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ELLMAN INTL., INC. 1135 RAILROAD AVE., ELLMAN BLDG. Hewlett, NY 11557 |
| Contact | Frank Lin |
| Correspondent | Frank Lin ELLMAN INTL., INC. 1135 RAILROAD AVE., ELLMAN BLDG. Hewlett, NY 11557 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-19 |
| Decision Date | 2000-05-26 |