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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 K113693
Device Name NIXALL TM WOUND AND SKIN CARE
Applicant
SERIOUSLY CLEAN LTD
1075 W. KATHRYN ST.
SUITE 6
NIXA,  MO  65714
Applicant Contact KIP GLASS
Correspondent
SERIOUSLY CLEAN LTD
1075 W. KATHRYN ST.
SUITE 6
NIXA,  MO  65714
Correspondent Contact KIP GLASS
Classification Product Code
FRO  
Date Received12/16/2011
Decision Date 12/11/2012
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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