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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 K873589
Device Name PERFECT SUNTANNING BED
Applicant
Wolff System Technology Corp.
487 Washington Ave.
Carlstadt,  NJ  07072
Applicant Contact STEPHEN M BRICKLEY
Correspondent
Wolff System Technology Corp.
487 Washington Ave.
Carlstadt,  NJ  07072
Correspondent Contact STEPHEN M BRICKLEY
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received09/04/1987
Decision Date 10/29/1987
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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