The following data is part of a premarket notification filed by Thantex Specialties, Inc. with the FDA for Isolyser Sharps Management System Sms.
| Device ID | K943626 |
| 510k Number | K943626 |
| Device Name: | ISOLYSER SHARPS MANAGEMENT SYSTEM SMS |
| Classification | Needle, Hypodermic, Single Lumen |
| 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 | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-26 |
| Decision Date | 1995-06-16 |