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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 K950295
Device Name WOUND CLOSURE/LACERATION TRAY
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 Received01/24/1995
Decision Date 04/18/1995
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
Recalls CDRH Recalls
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