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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 K902886
Device Name CUSTOMED BASIC PACK III
Applicant
CUSTOMED, INC.
CALL BOX 158
carolina puerto rico, 
Applicant Contact felix b santos
Correspondent
CUSTOMED, INC.
CALL BOX 158
carolina puerto rico, 
Correspondent Contact felix b santos
Regulation Number878.4370
Classification Product Code
KKX  
Date Received07/02/1990
Decision Date 09/19/1990
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
Recalls CDRH Recalls
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