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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Booth, Sun Tan
510(k) Number K882331
Device Name SHAW SUN SYSTEMS MODEL 1600
Applicant
Shaw Sun Systems
Rt. 2 Box 216
Brookline,  MO  65619
Applicant Contact SHAW, JR.
Correspondent
Shaw Sun Systems
Rt. 2 Box 216
Brookline,  MO  65619
Correspondent Contact SHAW, JR.
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received06/06/1988
Decision Date 06/22/1988
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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