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 |