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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 K800896
Device Name WOLFF SYSTEM
Applicant
Wolff System GmbH
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Wolff System GmbH
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received04/18/1980
Decision Date 05/30/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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