The following data is part of a premarket notification filed by O.r. Concepts, Inc. with the FDA for Reflective Blanket.
| Device ID | K860066 |
| 510k Number | K860066 |
| Device Name: | REFLECTIVE BLANKET |
| Classification | Bedding, Disposable, Medical |
| Applicant | O.R. CONCEPTS, INC. 1328 SHADY SPRINGS COURT Irving, TX 75060 |
| Contact | Staley, Jr. |
| Correspondent | Staley, Jr. O.R. CONCEPTS, INC. 1328 SHADY SPRINGS COURT Irving, TX 75060 |
| Product Code | KME |
| CFR Regulation Number | 880.6060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-06 |
| Decision Date | 1986-02-19 |