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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)
Applicant
ANGIOTECH
100 dennis drive
reading,  PA  19606
Applicant Contact kirsten stowell
Correspondent
ANGIOTECH
100 dennis drive
reading,  PA  19606
Correspodent Contact kirsten stowell
Regulation Number878.4840
Classification Product Code
NEW  
Date Received03/19/2012
Decision Date 07/13/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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