The following data is part of a premarket notification filed by Ellman Int'l Inc. with the FDA for Surgitron Radiolase Ii.
| Device ID | K042710 |
| 510k Number | K042710 |
| Device Name: | SURGITRON RADIOLASE II |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ELLMAN INT'L INC. 3333 ROYAL AVENUE Oceanside, NY 11572 -3625 |
| Contact | Frank Lin |
| Correspondent | Frank Lin 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 | 2004-09-30 |
| Decision Date | 2005-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841494104351 | K042710 | 000 |
| 00841494101794 | K042710 | 000 |
| 00841494101787 | K042710 | 000 |