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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name suture, surgical, absorbable, polydioxanone
510(k) Number K120827
Device Name QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE)
Original Applicant
ANGIOTECH
100 dennis drive
reading,  PA  19606
Original Contact kirsten stowell
Regulation Number878.4840
Classification Product Code
NEW  
Date Received03/19/2012
Decision Date 07/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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