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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 K881353
Device Name MTI WOLFF SYSTEM
Applicant
Health Systems Intl., Inc.
4230 Grove Ave.
Gurnee,  IL  60031
Applicant Contact DAVID L SUTHARD
Correspondent
Health Systems Intl., Inc.
4230 Grove Ave.
Gurnee,  IL  60031
Correspondent Contact DAVID L SUTHARD
Regulation Number878.4635
Classification Product Code
LEJ  
Date Received03/30/1988
Decision Date 04/06/1988
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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