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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 K863518
Device Name WEINGART MODEL 1000 SUNLAMP PRODUCT
Applicant
Weingart, Inc.
14730 Lima Rd.
Ft Wayne,  IN  46818
Applicant Contact HAL PAWLOWSKI
Correspondent
Weingart, Inc.
14730 Lima Rd.
Ft Wayne,  IN  46818
Correspondent Contact HAL PAWLOWSKI
Regulation Number878.4630
Classification Product Code
FTC  
Date Received09/09/1986
Decision Date 10/02/1986
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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