The following data is part of a premarket notification filed by Smr with the FDA for Smr Paragon Chair Table.
Device ID | K811623 |
510k Number | K811623 |
Device Name: | SMR PARAGON CHAIR TABLE |
Classification | Table, Examination, Medical, Powered |
Applicant | SMR 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LGX |
CFR Regulation Number | 878.4960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-06-09 |
Decision Date | 1981-07-02 |