The following data is part of a premarket notification filed by Ellman Int'l Inc. with the FDA for Surgi-max.
| Device ID | K061174 |
| 510k Number | K061174 |
| Device Name: | SURGI-MAX |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ELLMAN INT'L INC. 3333 ROYAL AVENUE Oceanside, NY 11572 -3625 |
| Contact | Jon Garito |
| Correspondent | Jon Garito 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 | 2006-04-27 |
| Decision Date | 2006-06-28 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SURGI-MAX 76502122 2909112 Live/Registered |
ELLIQUENCE, LLC 2003-03-31 |