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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rongeur, Powered
510(k) Number K022907
Device Name ANSPACH POWERED KERRISON SYSTEM (PKS)
Applicant
THE ANSPACH EFFORT, INC.
4500 RIVERSIDE DR.
PALM BEACH GARDENS,  FL  33410
Applicant Contact WILLIAM G CONETY
Correspondent
THE ANSPACH EFFORT, INC.
4500 RIVERSIDE DR.
PALM BEACH GARDENS,  FL  33410
Correspondent Contact WILLIAM G CONETY
Regulation Number882.4845
Classification Product Code
HAD  
Date Received09/03/2002
Decision Date 10/21/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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