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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 K023456
Device Name OXYBOX SYSTEM
Applicant
OXYFAST CORPORATION
11000 CEDAR AVE # 449
CLEVELAND,  OH  44106
Applicant Contact MELVYN BURKE
Correspondent
OXYFAST CORPORATION
11000 CEDAR AVE # 449
CLEVELAND,  OH  44106
Correspondent Contact MELVYN BURKE
Regulation Number878.5650
Classification Product Code
KPJ  
Date Received10/15/2002
Decision Date 02/24/2003
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
Recalls CDRH Recalls
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