510(k) K833868

IPOS G.L.P. SYSTEM by Ipos Luneburg — Product Code KFX

K833868 is an FDA 510(k) premarket notification submitted by Ipos Luneburg for the device "IPOS G.L.P. SYSTEM". The FDA issued a decision of Substantially Equivalent on November 28, 1983. The device falls under product code KFX (Assembly, Thigh/Knee/Shank/Ankle/Foot, External), a Class II device regulated under 21 CFR 890.3500. Ipos Luneburg has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1983
Date Received
November 7, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assembly, Thigh/Knee/Shank/Ankle/Foot, External
Device Class
Class II
Regulation Number
890.3500
Review Panel
PM
Submission Type