The following data is part of a premarket notification filed by Ellman Intl., Inc. with the FDA for Surgitron 120 Iec (also Known As Surgitron 4.0 Dual Rf.
| Device ID | K013255 |
| 510k Number | K013255 |
| Device Name: | SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF |
| 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 | 2001-09-28 |
| Decision Date | 2001-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841494108465 | K013255 | 000 |
| 00841494108472 | K013255 | 000 |
| 00841494106690 | K013255 | 000 |
| 00841494104887 | K013255 | 000 |
| 00841494104870 | K013255 | 000 |