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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 K080966
Device Name HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM
Applicant
AOTI LTD.
QUALTECH HOUSE
PARKMORE BUSINESS PARK WEST
GALWAY,  IE
Applicant Contact ROBBIE WALSH
Correspondent
AOTI LTD.
QUALTECH HOUSE
PARKMORE BUSINESS PARK WEST
GALWAY,  IE
Correspondent Contact ROBBIE WALSH
Regulation Number878.5650
Classification Product Code
KPJ  
Date Received04/04/2008
Decision Date 08/06/2008
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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