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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 K883848
Device Name KMI OXY-BAN
Applicant
Knight Medical, Inc.
18120 Ammi Trl.
Houston,  TX  77060
Applicant Contact KENNETH E CLARY
Correspondent
Knight Medical, Inc.
18120 Ammi Trl.
Houston,  TX  77060
Correspondent Contact KENNETH E CLARY
Regulation Number878.5650
Classification Product Code
KPJ  
Date Received09/12/1988
Decision Date 03/02/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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