The following data is part of a premarket notification filed by Lifestream Int'l, Inc. with the FDA for Light-touch And Surgi Light Fibers.
Device ID | K910726 |
510k Number | K910726 |
Device Name: | LIGHT-TOUCH AND SURGI LIGHT FIBERS |
Classification | Powered Laser Surgical Instrument |
Applicant | LIFESTREAM INT'L, INC. 2828 N.CRESCENT RIVER DR. The Woodlands, TX 77381 |
Contact | Gerald Abell |
Correspondent | Gerald Abell LIFESTREAM INT'L, INC. 2828 N.CRESCENT RIVER DR. The Woodlands, TX 77381 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-20 |
Decision Date | 1991-03-29 |