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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid
510(k) Number K122898
Device Name QUILL MONODERM 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 Number878.4493
Classification Product Code
GAM  
Date Received09/21/2012
Decision Date 10/22/2012
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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