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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K960520
Device Name LACERATION TRAY
Applicant
Medco Instruments, Inc.
C/O Burditt & Radzius
333 W. Wacker Dr., Suite 2600
Chicago,  IL  60606
Applicant Contact RICHARD O WOOD
Correspondent
Medco Instruments, Inc.
C/O Burditt & Radzius
333 W. Wacker Dr., Suite 2600
Chicago,  IL  60606
Correspondent Contact RICHARD O WOOD
Regulation Number880.6850
Classification Product Code
FRG  
Date Received02/06/1996
Decision Date 03/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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