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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K901109
Device Name WOUND TREATMENT KIT
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
Classification Product Code
FRO  
Date Received03/09/1990
Decision Date 06/06/1990
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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