The following data is part of a premarket notification filed by Ellman Intl., Inc. with the FDA for Surgitron Radiolase.
| Device ID | K992382 |
| 510k Number | K992382 |
| Device Name: | SURGITRON RADIOLASE |
| 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 | 1999-07-16 |
| Decision Date | 1999-10-14 |
| Summary: | summary |