Regnell Hydraulic Femoral Prothesis

FDA 510(k) K830285 · Besco Financial Service

Substantially Equivalent

510(k) numberK830285

Submission

Device name
Regnell Hydraulic Femoral Prothesis
Applicant
Besco Financial Service
Mchenry, IL, US
Received
January 27, 1983
Decision date
March 9, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KFX – Assembly, Thigh/Knee/Shank/Ankle/Foot, External
Device class
Class II (moderate risk)
Regulation
21 CFR 890.3500
Specialty
Physical Medicine

Other 510(k)s with product code KFX

510(k)DeviceApplicantDecision
K932184Sterile Lemaitre Glow 'N Tell TapeKFX · Traditional Vascutech, Inc.07/22/1993SE
K833868Ipos G.L.P. SystemKFX · Traditional Ipos Luneburg11/28/1983SE
K822240Ethylene Oxide Steriliz. Parametric Rel.KFX · Traditional American Mcgaw12/30/1982SE

Questions and answers

When was Regnell Hydraulic Femoral Prothesis cleared by the FDA?

Regnell Hydraulic Femoral Prothesis (K830285) received a 510(k) decision of Substantially Equivalent on March 9, 1983, 41 days after the submission was received.

What is the product code of K830285?

The FDA product code is KFX – Assembly, Thigh/Knee/Shank/Ankle/Foot, External, a Class II (moderate risk) device regulated under 21 CFR 890.3500.