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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 K853248
Device Name CHALLENGER SUNRISE
Applicant
Challenge Products, Inc.
Units 28-29 Roe Lee Ind Est.
Whalley New Rd., Blackburn,
Lancashire England Bb1 9s,  GB
Applicant Contact CARTER
Correspondent
Challenge Products, Inc.
Units 28-29 Roe Lee Ind Est.
Whalley New Rd., Blackburn,
Lancashire England Bb1 9s,  GB
Correspondent Contact CARTER
Regulation Number878.4630
Classification Product Code
FTC  
Date Received07/31/1985
Decision Date 09/13/1985
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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