The following data is part of a premarket notification filed by Advanced Medical Technologies, Inc. with the FDA for Maestro Mdtl Laser System.
Device ID | K053473 |
510k Number | K053473 |
Device Name: | MAESTRO MDTL LASER SYSTEM |
Classification | Lamp, Infrared, Therapeutic Heating |
Applicant | ADVANCED MEDICAL TECHNOLOGIES, INC. 12101 CULLEN BLVD., #A Houston, TX 77047 |
Contact | M. Joyce Heinrich |
Correspondent | M. Joyce Heinrich ADVANCED MEDICAL TECHNOLOGIES, INC. 12101 CULLEN BLVD., #A Houston, TX 77047 |
Product Code | ILY |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-12-14 |
Decision Date | 2006-02-03 |
Summary: | summary |