The following data is part of a premarket notification filed by O.r. Concepts, Inc. with the FDA for Thermalap.
| Device ID | K893212 |
| 510k Number | K893212 |
| Device Name: | THERMALAP |
| Classification | Drape, Surgical |
| Applicant | O.R. CONCEPTS, INC. 200 N. OAK ST. Roanoke, TX 76262 |
| Contact | Joe A Staley |
| Correspondent | Joe A Staley O.R. CONCEPTS, INC. 200 N. OAK ST. Roanoke, TX 76262 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-27 |
| Decision Date | 1989-06-01 |