The following data is part of a premarket notification filed by Ipos Luneburg with the FDA for Ipos Anti-adductus Shoe.
Device ID | K831690 |
510k Number | K831690 |
Device Name: | IPOS ANTI-ADDUCTUS SHOE |
Classification | Orthosis, Corrective Shoe |
Applicant | IPOS LUNEBURG 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KNP |
CFR Regulation Number | 890.3475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-24 |
Decision Date | 1983-06-24 |