ACRYL-X II SYSTEM— 510(k) K930629

Substantially Equivalent

Sonokinetics, Inc.

FDA 510(k) clearance K930629 for ACRYL-X II SYSTEM, Substantially Equivalent on 1994-01-21. Applicant: Sonokinetics, Inc.. Device class: 2.

Clearance details

Applicant: Sonokinetics, Inc.
Product code: Code LZV
Device class: Class 2
Regulation: 21 CFR 888.4580
Advisory panel: Orthopedic
Date received: 1993-02-08
Decision date: 1994-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoboken, NJ, 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.