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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 K854932
Device Name ECUMOL ULTRAVIOLET FACE TANNING UNITS
Applicant
MOTTEK INTL. CORP.
7402 E CAMELBACK RD STE A
SCOTTSDALE,  AZ  85251
Applicant Contact EDWARD SHAINER
Correspondent
MOTTEK INTL. CORP.
7402 E CAMELBACK RD STE A
SCOTTSDALE,  AZ  85251
Correspondent Contact EDWARD SHAINER
Regulation Number878.4630
Classification Product Code
FTC  
Date Received12/10/1985
Decision Date 01/30/1986
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
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