The following data is part of a premarket notification filed by A & A Medical Supplies Inc with the FDA for Huanqiu Heating Lamp.
Device ID | K052063 |
510k Number | K052063 |
Device Name: | HUANQIU HEATING LAMP |
Classification | Lamp, Infrared, Therapeutic Heating |
Applicant | A & A MEDICAL SUPPLIES INC 1800 CENTURY PARK E. SUITE 600 Los Angeles, CA 90067 |
Contact | George Su |
Correspondent | George Su A & A MEDICAL SUPPLIES INC 1800 CENTURY PARK E. SUITE 600 Los Angeles, CA 90067 |
Product Code | ILY |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-07-29 |
Decision Date | 2005-09-30 |
Summary: | summary |