The following data is part of a premarket notification filed by Thantex Specialties, Inc. with the FDA for Isolyser Sds Sharps Container.
| Device ID | K970547 |
| 510k Number | K970547 |
| Device Name: | ISOLYSER SDS SHARPS CONTAINER |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | THANTEX SPECIALTIES, INC. 4320 INTERNATIONAL BLVD, NW Norcross, GA 30093 |
| Contact | Tom Bonner |
| Correspondent | Tom Bonner THANTEX SPECIALTIES, INC. 4320 INTERNATIONAL BLVD, NW Norcross, GA 30093 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-12 |
| Decision Date | 1997-07-18 |
| Summary: | summary |