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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, Antimicrobial
510(k) Number K042526
Device Name DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX
Applicant
Medical Action Industries, Inc.
25 Heywood Rd.
Arden,  NC  28704
Applicant Contact ROBIN BLANKENBAKER
Correspondent
Medical Action Industries, Inc.
25 Heywood Rd.
Arden,  NC  28704
Correspondent Contact ROBIN BLANKENBAKER
Regulation Number878.4370
Classification Product Code
KKX  
Date Received09/17/2004
Decision Date 04/25/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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