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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 K885184
Device Name SHAW SUN SYSTEMS MODEL 2400
Applicant
SHAW SUN SYSTEMS
RT. 2 BOX 216
BROOKLINE,  MO  65619
Applicant Contact ROCKY L HILBURN
Correspondent
SHAW SUN SYSTEMS
RT. 2 BOX 216
BROOKLINE,  MO  65619
Correspondent Contact ROCKY L HILBURN
Regulation Number878.4630
Classification Product Code
FTC  
Date Received12/13/1988
Decision Date 01/09/1989
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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