The following data is part of a premarket notification filed by Thantex Specialties, Inc. with the FDA for Isolyser Orex Surgeon's Caps, Hoods, Bouffant Caps.
| Device ID | K942200 |
| 510k Number | K942200 |
| Device Name: | ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS |
| Classification | Accessory, Surgical Apparel |
| Applicant | THANTEX SPECIALTIES, INC. 4320 INTERNATIONAL BLVD. Norcross, GA 30093 |
| Contact | Thomas Bonner |
| Correspondent | Thomas Bonner THANTEX SPECIALTIES, INC. 4320 INTERNATIONAL BLVD. Norcross, GA 30093 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-05 |
| Decision Date | 1995-08-07 |