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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, steel, monofilament and multifilament, sterile
510(k) Number K081060
Device Name FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5
Applicant
CORE ESSENCE ORTHOPAEDICS, LLC
301 OXFORD VALLEY RD.
SUITE 905B
YARDLEY,  PA  19067
Applicant Contact SHAWN T HUXEL
Correspondent
CORE ESSENCE ORTHOPAEDICS, LLC
301 OXFORD VALLEY RD.
SUITE 905B
YARDLEY,  PA  19067
Correspondent Contact SHAWN T HUXEL
Regulation Number878.4495
Classification Product Code
GAQ  
Date Received04/14/2008
Decision Date 12/24/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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