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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 K853046
Device Name TAN MODEL I
Applicant
Philip Munsterman Tan, Inc.
747 E. College
Jacksonville,  IL  62650
Applicant Contact PHILIP MUNSTERMAN
Correspondent
Philip Munsterman Tan, Inc.
747 E. College
Jacksonville,  IL  62650
Correspondent Contact PHILIP MUNSTERMAN
Regulation Number878.4630
Classification Product Code
FTC  
Date Received07/19/1985
Decision Date 08/07/1985
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
Predetermined Change
Control Plan Authorized
No
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