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FDA 510(k)

REGNELL HYDRAULIC FEMORAL PROTHESIS

K-Number: K830285 · 1983-03-09

ApplicantBesco Financial Service
Decision Date1983-03-09
Product CodeKFX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

REGNELL HYDRAULIC FEMORAL PROTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Besco Financial Service. It received FDA 510(k) clearance on 1983-03-09 under 510(k) number K830285. The device is classified under product code KFX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REGNELL HYDRAULIC FEMORAL PROTHESIS?

REGNELL HYDRAULIC FEMORAL PROTHESIS is a medical device that received FDA 510(k) clearance on 1983-03-09. The listed applicant is Besco Financial Service. The 510(k) number is K830285.

When did REGNELL HYDRAULIC FEMORAL PROTHESIS receive FDA 510(k) clearance?

REGNELL HYDRAULIC FEMORAL PROTHESIS received FDA 510(k) clearance on 1983-03-09, under 510(k) number K830285.

Who is the listed applicant for REGNELL HYDRAULIC FEMORAL PROTHESIS?

The FDA 510(k) record lists Besco Financial Service as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REGNELL HYDRAULIC FEMORAL PROTHESIS?

The FDA product code for REGNELL HYDRAULIC FEMORAL PROTHESIS is KFX.

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Related Devices (Code: KFX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K932184STERILE LEMAITRE GLOW 'N TELL TAPEVascutech, Inc.K833868IPOS G.L.P. SYSTEMIpos LuneburgK822240ETHYLENE OXIDE STERILIZ. PARAMETRIC REL.American Mcgaw

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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