ACRYL-X SYSTEM TM— 510(k) K911548

Substantially Equivalent

Sonokinetics, Inc.

FDA 510(k) clearance K911548 for ACRYL-X SYSTEM TM, Substantially Equivalent on 1991-06-28. Applicant: Sonokinetics, Inc.. Device class: 2.

Clearance details

Applicant: Sonokinetics, Inc.
Product code: Code JDX
Device class: Class 2
Regulation: 21 CFR 888.4580
Advisory panel: Orthopedic
Date received: 1991-04-08
Decision date: 1991-06-28
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.