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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K930700
Device Name MEDLINES REPEAT PERFORMANCE SURGICAL PACK SYSTEM
Applicant
Medline Industries, Inc.
One Medline Pl.
Mundelein,  IL  60060
Applicant Contact DONALD BARHAM
Correspondent
Medline Industries, Inc.
One Medline Pl.
Mundelein,  IL  60060
Correspondent Contact DONALD BARHAM
Regulation Number878.4370
Classification Product Code
LRO  
Date Received02/10/1993
Decision Date 07/09/1993
Decision Substantially Equivalent - Kit (SESK)
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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