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510(k) K830285

REGNELL HYDRAULIC FEMORAL PROTHESIS by Besco Financial Service — Product Code KFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1983
Date Received
January 27, 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 for product code KFX

  • K932184 — STERILE LEMAITRE GLOW 'N TELL TAPE (July 22, 1993)
  • K833868 — IPOS G.L.P. SYSTEM (November 28, 1983)
  • K822240 — ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. (December 30, 1982)