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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 K042131
Device Name PROMEDICAL SURGICAL DRAPES
Applicant
PROMEDICAL PRODUCTS CO., LTD.
125 CLEMENTS AVE.
STARKVILLE,  MS  39759
Applicant Contact BOYD HARRIS
Correspondent
PROMEDICAL PRODUCTS CO., LTD.
125 CLEMENTS AVE.
STARKVILLE,  MS  39759
Correspondent Contact BOYD HARRIS
Regulation Number878.4370
Classification Product Code
KKX  
Date Received08/09/2004
Decision Date 12/10/2004
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
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