The following data is part of a premarket notification filed by Thantex Specialties, Inc. with the FDA for Orex Isolation Gown.
| Device ID | K945223 |
| 510k Number | K945223 |
| Device Name: | OREX ISOLATION GOWN |
| Classification | Gown, Isolation, Surgical |
| Applicant | THANTEX SPECIALTIES, INC. 251 EXCHANGE PLACE Herndon, VA 22070 -4822 |
| Contact | Tom Bonner |
| Correspondent | Tom Bonner THANTEX SPECIALTIES, INC. 251 EXCHANGE PLACE Herndon, VA 22070 -4822 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-26 |
| Decision Date | 1995-04-25 |