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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 K925016
Device Name PREP SHAVE KIT (NON-STERILE)
Applicant
Customed, Inc.
Calle Igualdad #7
Fajardo,  PR  00738
Applicant Contact FELIX B SANTOS
Correspondent
Customed, Inc.
Calle Igualdad #7
Fajardo,  PR  00738
Correspondent Contact FELIX B SANTOS
Regulation Number878.4370
Classification Product Code
LRO  
Date Received09/24/1992
Decision Date 04/26/1993
Decision Substantially Equivalent (SESE)
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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