The following data is part of a premarket notification filed by Thantex Specialties, Inc. with the FDA for Orex Surgeon's Gown.
| Device ID | K944827 |
| 510k Number | K944827 |
| Device Name: | OREX SURGEON'S GOWN |
| Classification | Gown, 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 | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-29 |
| Decision Date | 1995-02-28 |