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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, nonabsorbable, synthetic, polypropylene
510(k) Number K113800
Device Name QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE
Applicant
ANGIOTECH
100 DENNIS DRIVE
READING,  PA  19606
Applicant Contact KIRSTEN STOWELL
Correspondent
ANGIOTECH
100 DENNIS DRIVE
READING,  PA  19606
Correspondent Contact KIRSTEN STOWELL
Regulation Number878.5010
Classification Product Code
GAW  
Date Received12/23/2011
Decision Date 01/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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