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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 K945537
Device Name T-GUARD
Applicant
Med ET AL Development
815 Tadlock Pl.
Matthews,  NC  28105
Applicant Contact E ZILBER
Correspondent
Med ET AL Development
815 Tadlock Pl.
Matthews,  NC  28105
Correspondent Contact E ZILBER
Regulation Number890.3475
Classification Product Code
LQX  
Date Received11/14/1994
Decision Date 03/23/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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