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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scissors, General, Surgical
510(k) Number K902828
Device Name SUTURE REMOVAL TRAY
Applicant
Orion Life Systems, Inc.
124 Messner Dr.
Wheeling,  IL  60090
Applicant Contact JOHN L LAEMMAR
Correspondent
Orion Life Systems, Inc.
124 Messner Dr.
Wheeling,  IL  60090
Correspondent Contact JOHN L LAEMMAR
Regulation Number878.4800
Classification Product Code
LRW  
Date Received06/28/1990
Decision Date 08/08/1990
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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