The following data is part of a premarket notification filed by Thantex Specialties, Inc. with the FDA for Orex Medical Bedding.
| Device ID | K944953 |
| 510k Number | K944953 |
| Device Name: | OREX MEDICAL BEDDING |
| Classification | Bedding, Disposable, Medical |
| Applicant | THANTEX SPECIALTIES, INC. 251 EXCHANGE PLACE Herndon, VA 22070 -4822 |
| Contact | Thomas B Bonner |
| Correspondent | Thomas B Bonner THANTEX SPECIALTIES, INC. 251 EXCHANGE PLACE Herndon, VA 22070 -4822 |
| Product Code | KME |
| CFR Regulation Number | 880.6060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-07 |
| Decision Date | 1994-12-02 |