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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 K860198
Device Name MODEL 7500/000 KETTLER HOLIDAY SOLAR SUN TANNING
Applicant
Mottek Intl. Corp.
7402 E Camelback Rd. Suite A
Scottsdale,  AZ  85251
Applicant Contact EDWARD SHAINER
Correspondent
Mottek Intl. Corp.
7402 E Camelback Rd. Suite A
Scottsdale,  AZ  85251
Correspondent Contact EDWARD SHAINER
Regulation Number878.4630
Classification Product Code
FTC  
Date Received01/22/1986
Decision Date 02/18/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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