The following data is part of a premarket notification filed by Wuestec Medical, Inc. with the FDA for Superstand 300.
| Device ID | K935123 |
| 510k Number | K935123 |
| Device Name: | SUPERSTAND 300 |
| Classification | Tube Mount, X-ray, Diagnostic |
| Applicant | WUESTEC MEDICAL, INC. 1812 15TH ST. BROOKLEY INDUSTRIAL COMPLEX Mobile, AL 36615 |
| Contact | Michael W Scott |
| Correspondent | Michael W Scott WUESTEC MEDICAL, INC. 1812 15TH ST. BROOKLEY INDUSTRIAL COMPLEX Mobile, AL 36615 |
| Product Code | IYB |
| CFR Regulation Number | 892.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-28 |
| Decision Date | 1996-03-27 |