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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 K050322
Device Name MICROTEK EQUIPMENT DRAPES
Applicant
MICROTEK MEDICAL, INC.
512 LEHMBERG RD.
COLUMBUS,  MS  39702
Applicant Contact THOMAS BONNER
Correspondent
MICROTEK MEDICAL, INC.
512 LEHMBERG RD.
COLUMBUS,  MS  39702
Correspondent Contact THOMAS BONNER
Regulation Number878.4370
Classification Product Code
KKX  
Date Received02/09/2005
Decision Date 05/17/2005
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
Recalls CDRH Recalls
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