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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 K851535
Device Name PHILIPS UV-A SOLARIUM TYPE HP 3140
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 Received04/16/1985
Decision Date 05/01/1985
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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