KLEIN WIRE TIGHTENER/BIONIC WIRE— 510(k) K833726

Name: FDA 510(k) clearance K833726
Creator: U.S. Food and Drug Administration
Published: 1983-12-22

Substantially Equivalent

Bionic Instrument Corp.

FDA 510(k) clearance K833726 for KLEIN WIRE TIGHTENER/BIONIC WIRE, Substantially Equivalent on 1983-12-22. Applicant: Bionic Instrument Corp.. Device class: 1.

Clearance details

Applicant: Bionic Instrument Corp.
Product code: Code HXS
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1983-10-24
Decision date: 1983-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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