The following data is part of a premarket notification filed by Ellman Intl. Mfg., Inc. with the FDA for Surgitron.
| Device ID | K911461 |
| 510k Number | K911461 |
| Device Name: | SURGITRON |
| Classification | Laryngoscope, Endoscope |
| Applicant | ELLMAN INTL. MFG., INC. 1135 RAILROAD AVE. Hewlett, NY 11557 |
| Contact | Richard Lanzillotto |
| Correspondent | Richard Lanzillotto ELLMAN INTL. MFG., INC. 1135 RAILROAD AVE. Hewlett, NY 11557 |
| Product Code | GCI |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-03 |
| Decision Date | 1991-04-25 |
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 |