The following data is part of a premarket notification filed by Tecnomed, Inc. with the FDA for Allmec 90/15.
Device ID | K811196 |
510k Number | K811196 |
Device Name: | ALLMEC 90/15 |
Classification | Table, Radiologic |
Applicant | TECNOMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KXJ |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-04-30 |
Decision Date | 1981-06-09 |