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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 K130078
Device Name QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
Applicant
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
100 DENNIS DR.
READING,  PA  19606
Applicant Contact KIRSTEN STOWELL
Correspondent
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
100 DENNIS DR.
READING,  PA  19606
Correspondent Contact KIRSTEN STOWELL
Regulation Number878.5010
Classification Product Code
GAW  
Date Received01/14/2013
Decision Date 02/28/2013
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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