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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 K813307
Device Name UVA HEX UNIT
Applicant
SUN SHANTY, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
SUN SHANTY, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4630
Classification Product Code
FTC  
Date Received11/23/1981
Decision Date 12/31/1981
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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