The following data is part of a premarket notification filed by Heraeus Surgical, Inc. with the FDA for Lasersonics Parascan Dosimeter Device.
Device ID | K955734 |
510k Number | K955734 |
Device Name: | LASERSONICS PARASCAN DOSIMETER DEVICE |
Classification | Powered Laser Surgical Instrument |
Applicant | HERAEUS SURGICAL, INC. 575 COTTONWOOD DR. Milpitas, CA 95035 -7434 |
Contact | Robert Milder |
Correspondent | Robert Milder 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 | 1995-12-18 |
Decision Date | 1996-02-13 |