The following data is part of a premarket notification filed by Microlight Corporation Of America with the FDA for Ml830tp.
| Device ID | K080786 |
| 510k Number | K080786 |
| Device Name: | ML830TP |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | MICROLIGHT CORPORATION OF AMERICA 2935 HIGHLAND LAKES DR. Missouri City, TX 77459 -4218 |
| Contact | Fred A Simpson |
| Correspondent | Fred A Simpson MICROLIGHT CORPORATION OF AMERICA 2935 HIGHLAND LAKES DR. Missouri City, TX 77459 -4218 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-20 |
| Decision Date | 2008-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859626006275 | K080786 | 000 |