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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 K853177
Device Name ECUMOL ULTRAVIOLET SUNTANNNING BEDS
Applicant
MOTTEK INTL. CORP.
7402 E CAMELBACK RD STE A
SCOTTSDALE,  AZ  85251
Applicant Contact HARRY H MOTTEK
Correspondent
MOTTEK INTL. CORP.
7402 E CAMELBACK RD STE A
SCOTTSDALE,  AZ  85251
Correspondent Contact HARRY H MOTTEK
Regulation Number878.4630
Classification Product Code
FTC  
Date Received07/30/1985
Decision Date 08/13/1985
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
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