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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 K864546
Device Name MAXI-TAN DEVICE
Applicant
National Biological Corp.
1532 Enterprise Pkwy.
Twinsburg,  OH  44087
Applicant Contact HOWARD J DRECHSLER
Correspondent
National Biological Corp.
1532 Enterprise Pkwy.
Twinsburg,  OH  44087
Correspondent Contact HOWARD J DRECHSLER
Regulation Number878.4630
Classification Product Code
FTC  
Date Received11/19/1986
Decision Date 01/09/1987
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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