The following data is part of a premarket notification filed by Heraeus Lasersonics, Inc. with the FDA for Co2 Laser Systems & Arthroguide Co2 Laser Fiber.
Device ID | K893832 |
510k Number | K893832 |
Device Name: | CO2 LASER SYSTEMS & ARTHROGUIDE CO2 LASER FIBER |
Classification | Powered Laser Surgical Instrument |
Applicant | HERAEUS LASERSONICS, INC. 575 COTTONWOOD DR. Milpitas, CA 95035 |
Contact | Donna Page |
Correspondent | Donna Page 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 | 1989-05-24 |
Decision Date | 1989-08-09 |