The following data is part of a premarket notification filed by Wuestec Medical, Inc. with the FDA for Superstand 3000.
Device ID | K933253 |
510k Number | K933253 |
Device Name: | SUPERSTAND 3000 |
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 | 1993-07-02 |
Decision Date | 1993-08-16 |