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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture Removal Kit
510(k) Number K925015
Device Name STERILE SUTURE REMOVAL KIT
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 Number878.4800
Classification Product Code
MCZ  
Date Received09/24/1992
Decision Date 06/07/1993
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
Recalls CDRH Recalls
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