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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 K902884
Device Name CUSTOMED BASIC PACK I
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
Predetermined Change
Control Plan Authorized		 No
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