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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 K071989
Device Name QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL
Applicant
Surgical Specialties Corp
100 Dennis Dr.
Reading,  PA  19606
Applicant Contact KEVIN BENTLEY
Correspondent
Surgical Specialties Corp
100 Dennis Dr.
Reading,  PA  19606
Correspondent Contact KEVIN BENTLEY
Regulation Number878.4840
Classification Product Code
NEW  
Date Received07/20/2007
Decision Date 08/06/2007
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
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