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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 K850205
Device Name PHILIPS UV-A SOLARIUM TYPE HP 3127-SUNLAMP
Applicant
PHILIPS INT'L B.V.
EUROPAWEG 8
9723 AS GRONINGEN
THE NETHERLANDS,  NL
Applicant Contact EMMELKAMP
Correspondent
PHILIPS INT'L B.V.
EUROPAWEG 8
9723 AS GRONINGEN
THE NETHERLANDS,  NL
Correspondent Contact EMMELKAMP
Regulation Number878.4630
Classification Product Code
FTC  
Date Received01/18/1985
Decision Date 02/21/1985
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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