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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical
510(k) Number K050508
Device Name HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES
Applicant
Haywood Vocational Opportunities
56 Scates St.
Waynesville,  NC  28786
Applicant Contact TIM KELLEY
Correspondent
Haywood Vocational Opportunities
56 Scates St.
Waynesville,  NC  28786
Correspondent Contact TIM KELLEY
Regulation Number878.4370
Classification Product Code
KKX  
Date Received02/28/2005
Decision Date 04/27/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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