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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 K871237
Device Name SUN CAPSULE I & II SUNTANNING BOOTH
Applicant
Sun Capsule, Inc.
42 B Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact EUGENE CHARETTE
Correspondent
Sun Capsule, Inc.
42 B Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact EUGENE CHARETTE
Regulation Number878.4630
Classification Product Code
FTC  
Date Received03/27/1987
Decision Date 04/23/1987
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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