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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Booth, Sun Tan
510(k) Number K923759
Device Name FLUORESCENT T12 UVA TANNING LAMP
Applicant
Quality Lamp, Inc.
P.O. Box 6244
Station B
Canton,  OH  44706
Applicant Contact KENNETH ELL
Correspondent
Quality Lamp, Inc.
P.O. Box 6244
Station B
Canton,  OH  44706
Correspondent Contact KENNETH ELL
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received07/28/1992
Decision Date 12/09/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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