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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K964011
Device Name SUCTION CATHETER TRAY PRODUCT NO. 900277
Applicant
Customed, Inc.
Calle Igualdad #7
Fajardo,  PR  00738
Applicant Contact OSVALDO RODRIGUEZ
Correspondent
Customed, Inc.
Calle Igualdad #7
Fajardo,  PR  00738
Correspondent Contact OSVALDO RODRIGUEZ
Regulation Number878.4370
Classification Product Code
LRO  
Date Received10/07/1996
Decision Date 11/25/1996
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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