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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Surgical, Instrument
510(k) Number K861530
Device Name SURGICAL PACKS, KITS AND TRAYS
Applicant
Medical Concepts Development, Inc.
330 Chester St.
St. Paul,  MN  55107
Applicant Contact LEE W ANNETT
Correspondent
Medical Concepts Development, Inc.
330 Chester St.
St. Paul,  MN  55107
Correspondent Contact LEE W ANNETT
Regulation Number878.4800
Classification Product Code
FSM  
Date Received04/24/1986
Decision Date 05/30/1986
Decision Substantially Equivalent - With Drug (SESD)
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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