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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chamber, Oxygen, Topical, Extremity
510(k) Number K112634
Device Name NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP
Applicant
INOTEC AMD LTD.
2995 STEVEN MARTIN DR.
FAIRFAX,  VA  22031
Applicant Contact Diane Horwitz
Correspondent
INOTEC AMD LTD.
2995 STEVEN MARTIN DR.
FAIRFAX,  VA  22031
Correspondent Contact Diane Horwitz
Regulation Number878.5650
Classification Product Code
KPJ  
Date Received09/09/2011
Decision Date 07/03/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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