The following data is part of a premarket notification filed by Heraeus Surgical, Inc. with the FDA for Lasersonics Surgical Laser Systems And Accessories.
Device ID | K943716 |
510k Number | K943716 |
Device Name: | LASERSONICS SURGICAL LASER SYSTEMS AND ACCESSORIES |
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 | 1994-08-01 |
Decision Date | 1995-03-14 |