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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Ultraviolet, Dermatological
510(k) Number K861570
Device Name ALPHA TAN 1000 AND ALPHA TAN 1200
Applicant
Midwest Marketing Service
109 E. Main St.
Klemme,  IA  50449
Applicant Contact NOEL KATTER
Correspondent
Midwest Marketing Service
109 E. Main St.
Klemme,  IA  50449
Correspondent Contact NOEL KATTER
Regulation Number878.4630
Classification Product Code
FTC  
Date Received04/28/1986
Decision Date 05/13/1986
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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