BONE BAND— 510(k) K983685

Substantially Equivalent

Chapel and Assoc.

FDA 510(k) clearance K983685 for BONE BAND, Substantially Equivalent on 1998-12-04. Applicant: Chapel and Assoc.. Device class: 2.

Clearance details

Applicant: Chapel and Assoc.
Product code: Code LYT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1998-10-20
Decision date: 1998-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denton, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.