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510(k) K833868

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

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

Other clearances by Ipos Luneburg

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  • K831690 — IPOS ANTI-ADDUCTUS SHOE (June 24, 1983)
  • K802976 — CARBONACRYL (December 19, 1980)
  • K802977 — IPOCARBON STRETCH STOCKINETTE (December 19, 1980)
  • K800749 — IPOCON 7 (July 28, 1980)
  • K800715 — OHC DYNAMIC CLUB FOOT BRACE (May 2, 1980)
  • K800716 — ORTHOTIC LEG GAIT CORRECTOR DEVICE (May 2, 1980)

Other clearances for product code KFX

  • K932184 — STERILE LEMAITRE GLOW 'N TELL TAPE (July 22, 1993)
  • K830285 — REGNELL HYDRAULIC FEMORAL PROTHESIS (March 9, 1983)
  • K822240 — ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. (December 30, 1982)