The following data is part of a premarket notification filed by Prime Herbs Corporation with the FDA for Precision Tdp, Heat And Infrared Lamps And Marvel And Wonder Lamps.
| Device ID | K081720 |
| 510k Number | K081720 |
| Device Name: | PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | PRIME HERBS CORPORATION 1872 HARTOG DRIVE San Jose, CA 95131 |
| Contact | Genevieve Hsia |
| Correspondent | Genevieve Hsia PRIME HERBS CORPORATION 1872 HARTOG DRIVE San Jose, CA 95131 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-18 |
| Decision Date | 2009-06-16 |
| Summary: | summary |