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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Finger-Sucking
510(k) Number K864870
Device Name THUMBSHELPER POWER RING
Applicant
Levolon Company, Inc.
343 Pineridge Dr.
Forest Park,  GA  30050
Applicant Contact CHARLES R LEVERETTE
Correspondent
Levolon Company, Inc.
343 Pineridge Dr.
Forest Park,  GA  30050
Correspondent Contact CHARLES R LEVERETTE
Regulation Number890.3475
Classification Product Code
LQX  
Date Received12/12/1986
Decision Date 02/12/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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