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 |