The following data is part of a premarket notification filed by Heraeus Surgical, Inc. with the FDA for Lasersonics Nd:yag Cylindrically Diffusing Sterile Disposable Fiber.
| Device ID | K960636 |
| 510k Number | K960636 |
| Device Name: | LASERSONICS ND:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABLE FIBER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | HERAEUS SURGICAL, INC. 575 COTTONWOOD DR. Milpitas, CA 95035 -7434 |
| Contact | Lisa Mcgrath |
| Correspondent | Lisa Mcgrath HERAEUS SURGICAL, INC. 575 COTTONWOOD DR. Milpitas, CA 95035 -7434 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-14 |
| Decision Date | 1996-08-21 |
| Summary: | summary |