The following data is part of a premarket notification filed by Trace America, Inc. with the FDA for Uric Acid - Incorporating Dynamic Stabilization Technology - (dst).
Device ID | K971485 |
510k Number | K971485 |
Device Name: | URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) |
Classification | Acid, Uric, Uricase (u.v.) |
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 | CDO |
CFR Regulation Number | 862.1775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-04-23 |
Decision Date | 1997-05-27 |