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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manipulator, Plunger-Like Joint
510(k) Number K112606
Device Name ACTIVATOR V-E
Applicant
ACTIVATOR METHODS INTERNATIONAL LTD.
2950 N. SEVENTH ST.
PHOENIX,  AZ  85014
Applicant Contact ARLAN W FUHR
Correspondent
ACTIVATOR METHODS INTERNATIONAL LTD.
2950 N. SEVENTH ST.
PHOENIX,  AZ  85014
Correspondent Contact ARLAN W FUHR
Classification Product Code
LXM  
Date Received09/08/2011
Decision Date 03/06/2012
Decision Substantially Equivalent (SESE)
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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