ANSPACH POWERED KERRISON SYSTEM (PKS)— 510(k) K022907

Name: FDA 510(k) clearance K022907
Creator: U.S. Food and Drug Administration
Published: 2002-10-21

Substantially Equivalent

The Anspach Effort, Inc.

FDA 510(k) clearance K022907 for ANSPACH POWERED KERRISON SYSTEM (PKS), Substantially Equivalent on 2002-10-21. Applicant: The Anspach Effort, Inc.. Device class: 2.

Clearance details

Applicant: The Anspach Effort, Inc.
Product code: Code HAD
Device class: Class 2
Regulation: 21 CFR 882.4845
Advisory panel: Neurology
Date received: 2002-09-03
Decision date: 2002-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Beach Gardens, FL, US

Download summary PDF View on FDA.gov ↗

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