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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 K954212
Device Name CONTAMINATION CONTAINMENT DRAPE
Applicant
Engineering Controls For Medicine
3921 Overton Park E.
Fort Worth,  TX  76109
Applicant Contact JOHN BUSCH
Correspondent
Engineering Controls For Medicine
3921 Overton Park E.
Fort Worth,  TX  76109
Correspondent Contact JOHN BUSCH
Regulation Number878.4370
Classification Product Code
KKX  
Date Received09/07/1995
Decision Date 10/23/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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