The following data is part of a premarket notification filed by Ellman International, Inc. with the FDA for Surgitron 4.0 Dual Rf S5-iec.
| Device ID | K123366 |
| 510k Number | K123366 |
| Device Name: | SURGITRON 4.0 DUAL RF S5-IEC |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ELLMAN INTERNATIONAL, INC. 3333 ROYAL AVENUE Oceanside, NY 11572 |
| Contact | Alison Sathe |
| Correspondent | Alison Sathe ELLMAN INTERNATIONAL, INC. 3333 ROYAL AVENUE Oceanside, NY 11572 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-31 |
| Decision Date | 2013-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841494108502 | K123366 | 000 |
| 00841494107130 | K123366 | 000 |
| 00841494105167 | K123366 | 000 |
| 00841494104863 | K123366 | 000 |