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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 K131224
Device Name SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE
Applicant
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
100 DENNIS DR.
READING,  PA  19606
Applicant Contact KRISTEN STOWELL
Correspondent
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
100 DENNIS DR.
READING,  PA  19606
Correspondent Contact KRISTEN STOWELL
Regulation Number878.5010
Classification Product Code
GAW  
Date Received04/30/2013
Decision Date 05/16/2013
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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