The following data is part of a premarket notification filed by Ipos Luneburg with the FDA for Ipos G.l.p. System.
Device ID | K833868 |
510k Number | K833868 |
Device Name: | IPOS G.L.P. SYSTEM |
Classification | Assembly, Thigh/knee/shank/ankle/foot, External |
Applicant | IPOS LUNEBURG 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KFX |
CFR Regulation Number | 890.3500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-11-07 |
Decision Date | 1983-11-28 |