The following data is part of a premarket notification filed by Trace America, Inc. with the FDA for Ammonia-incorporating Dynamic Stabilization Technology (dst).
| Device ID | K974620 |
| 510k Number | K974620 |
| Device Name: | AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) |
| Classification | Enzymatic Method, Ammonia |
| Applicant | TRACE AMERICA, INC. 7260 NORTH WEST 58TH ST. Miami, FL 33166 |
| Contact | David Johnson |
| Correspondent | David Johnson TRACE AMERICA, INC. 7260 NORTH WEST 58TH ST. Miami, FL 33166 |
| Product Code | JIF |
| CFR Regulation Number | 862.1065 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-11 |
| Decision Date | 1998-01-02 |