The following data is part of a premarket notification filed by Thantex Specialties, Inc. with the FDA for Orex Surgeon's Vest.
| Device ID | K961083 |
| 510k Number | K961083 |
| Device Name: | OREX SURGEON'S VEST |
| Classification | Gown, Surgical |
| Applicant | THANTEX SPECIALTIES, INC. 4320 INTERNATIONAL BLVD, NW Norcross, GA 30093 |
| Contact | Thomas Bonner |
| Correspondent | Thomas Bonner THANTEX SPECIALTIES, INC. 4320 INTERNATIONAL BLVD, NW Norcross, GA 30093 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-19 |
| Decision Date | 1996-08-23 |
| Summary: | summary |