TENDON ROD MODEL OR41PO3-6— 510(k) K781943

Name: FDA 510(k) clearance K781943
Creator: U.S. Food and Drug Administration
Published: 1978-12-04

Substantially Equivalent

Holter-Hausner Intl.

FDA 510(k) clearance K781943 for TENDON ROD MODEL OR41PO3-6, Substantially Equivalent on 1978-12-04. Applicant: Holter-Hausner Intl.. Device class: 2.

Clearance details

Applicant: Holter-Hausner Intl.
Product code: Code HXA
Device class: Class 2
Regulation: 21 CFR 888.3025
Advisory panel: Orthopedic
Date received: 1978-11-17
Decision date: 1978-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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