The following data is part of a premarket notification filed by Medical Laser Technology, Inc. with the FDA for Mlt 20.
Device ID | K953800 |
510k Number | K953800 |
Device Name: | MLT 20 |
Classification | Powered Laser Surgical Instrument |
Applicant | MEDICAL LASER TECHNOLOGY, INC. 2104-A MOON STATION DR. Kennesaw, GA 30144 |
Contact | James E Bishop |
Correspondent | James E Bishop MEDICAL LASER TECHNOLOGY, INC. 2104-A MOON STATION DR. Kennesaw, GA 30144 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-08-14 |
Decision Date | 1995-11-29 |