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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 K904694
Device Name CUSTOMED ANGIODRAPE PACK FEMORAL
Applicant
CUSTOMED, INC.
CALL BOX 158
carolina puerto rico, 
Applicant Contact jose m negron
Correspondent
CUSTOMED, INC.
CALL BOX 158
carolina puerto rico, 
Correspondent Contact jose m negron
Regulation Number878.4370
Classification Product Code
KKX  
Date Received10/16/1990
Decision Date 01/02/1991
Decision substantially equivalent - kit (SESK)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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