The following data is part of a premarket notification filed by Ellman Intl., Inc. with the FDA for Surgitron.
Device ID | K980170 |
510k Number | K980170 |
Device Name: | SURGITRON |
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 | 1998-01-20 |
Decision Date | 1998-06-29 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SURGITRON 76623138 3037439 Live/Registered |
CYNOSURE, LLC 2004-12-03 |
SURGITRON 74423469 not registered Dead/Abandoned |
SURGITRON INTERNATIONAL, INC. 1993-08-12 |
SURGITRON 72095466 0706261 Dead/Cancelled |
Wuerth, Robert C. 1960-04-20 |