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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 K080680
Device Name QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE
Applicant
Surgical Specialties Corp
13921 Park Center Rd.
Suite 200
Herndon,  VA  20171
Applicant Contact TRUDY D ESTRIDGE
Correspondent
Surgical Specialties Corp
13921 Park Center Rd.
Suite 200
Herndon,  VA  20171
Correspondent Contact TRUDY D ESTRIDGE
Regulation Number878.4840
Classification Product Code
NEW  
Date Received03/10/2008
Decision Date 03/21/2008
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
Predetermined Change
Control Plan Authorized		 No
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