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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 ROAD, BLACKBURN,
LANCASHIRE ENGLAND BB1 9S,  GB
Applicant Contact CARTER
Correspondent
CHALLENGE PRODUCTS, INC.
UNITS 28-29 ROE LEE IND EST.
WHALLEY NEW ROAD, 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
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