The following data is part of a premarket notification filed by Heraeus Lasersonics, Inc. with the FDA for Sterile Disposable Infratip.
| Device ID | K895918 |
| 510k Number | K895918 |
| Device Name: | STERILE DISPOSABLE INFRATIP |
| Classification | Powered Laser Surgical Instrument |
| Applicant | HERAEUS LASERSONICS, INC. 575 COTTONWOOD DR. Milpitas, CA 95035 |
| Contact | Page, B.s. |
| Correspondent | Page, B.s. HERAEUS LASERSONICS, INC. 575 COTTONWOOD DR. Milpitas, CA 95035 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-10 |
| Decision Date | 1989-12-14 |