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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 K844039
Device Name AZTECH INDUSTRIES SUNTANNING BED AZ100
Applicant
AZTECH INDUSTRIES, INC.
5335 S.W. 42ND
PORTLAND,  OR  97221
Applicant Contact MARK ARMSTRONG
Correspondent
AZTECH INDUSTRIES, INC.
5335 S.W. 42ND
PORTLAND,  OR  97221
Correspondent Contact MARK ARMSTRONG
Regulation Number878.4630
Classification Product Code
FTC  
Date Received10/16/1984
Decision Date 11/05/1984
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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