The following data is part of a premarket notification filed by Lhasa Medical, Inc. with the FDA for Tdp Cq-27 Heat Lamp.
| Device ID | K003538 |
| 510k Number | K003538 |
| Device Name: | TDP CQ-27 HEAT LAMP |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | LHASA MEDICAL, INC. 234 LIBBEY PKWY. Weymouth, MA 02189 |
| Contact | Kyung P Riihimaki |
| Correspondent | Kyung P Riihimaki LHASA MEDICAL, INC. 234 LIBBEY PKWY. Weymouth, MA 02189 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-16 |
| Decision Date | 2001-06-04 |