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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 K800744
Device Name SUNTANA SUNBED #SB-1 & SUNBRELLA #SU-1
Applicant
Sun Ind., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Sun Ind., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received04/03/1980
Decision Date 06/04/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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