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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 K943656
Device Name ALPHA SOLAR SYSTEM TANNING BED
Applicant
Heartland Tan Systems
120 Cleveland St.
Locust Grove,  GA  30248
Applicant Contact KRISTIN A TIFFANY
Correspondent
Heartland Tan Systems
120 Cleveland St.
Locust Grove,  GA  30248
Correspondent Contact KRISTIN A TIFFANY
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received07/28/1994
Decision Date 08/15/1994
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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