The following data is part of a premarket notification filed by Lifestream Int'l, Inc. with the FDA for Light-touch/gs 905250 Nd:yag Laser Micro Pro Endos.
Device ID | K891909 |
510k Number | K891909 |
Device Name: | LIGHT-TOUCH/GS 905250 ND:YAG LASER MICRO PRO ENDOS |
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 | 1989-03-27 |
Decision Date | 1989-05-26 |