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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 K864920
Device Name SCANLAN (TM) INSTRUMENT TRAY
Applicant
Scanlan Intl., Inc.
One Scanlan Plz.
Saint Paul,  MN  55107
Applicant Contact KENNETH R BLAKE
Correspondent
Scanlan Intl., Inc.
One Scanlan Plz.
Saint Paul,  MN  55107
Correspondent Contact KENNETH R BLAKE
Regulation Number878.4800
Classification Product Code
FSM  
Date Received12/16/1986
Decision Date 01/12/1987
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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