The following data is part of a premarket notification filed by Thantex Specialties, Inc. with the FDA for Isolyser (8x4 12 Ply X-ray Detectable).
| Device ID | K940763 |
| 510k Number | K940763 |
| Device Name: | ISOLYSER (8X4 12 PLY X-RAY DETECTABLE) |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | THANTEX SPECIALTIES, INC. 4320 INTERNATIONAL BLVD, NW Norcross, GA 30093 |
| Contact | Travis Honeycutt |
| Correspondent | Travis Honeycutt THANTEX SPECIALTIES, INC. 4320 INTERNATIONAL BLVD, NW Norcross, GA 30093 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-18 |
| Decision Date | 1994-05-02 |