The following data is part of a premarket notification filed by Ellman Intl., Inc. with the FDA for Surgitron.
| Device ID | K955158 |
| 510k Number | K955158 |
| Device Name: | SURGITRON |
| Classification | Apparatus, Cautery, Radiofrequency, Ac-powered |
| Applicant | ELLMAN INTL., INC. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Contact | Richard C Lanzillotto |
| Correspondent | Richard C Lanzillotto ELLMAN INTL., INC. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Product Code | HQR |
| CFR Regulation Number | 886.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-13 |
| Decision Date | 1996-02-09 |
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 |