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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 K140127
Device Name FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP
Applicant
PONTIS ORTHOPAEDICS, LLC
2299 POST STREET, SUITE 103
SAN FRANCISCO,  CA  94115
Applicant Contact LEONARD GORDON
Correspondent
PONTIS ORTHOPAEDICS, LLC
2299 POST STREET, SUITE 103
SAN FRANCISCO,  CA  94115
Correspondent Contact LEONARD GORDON
Regulation Number878.4495
Classification Product Code
GAQ  
Date Received01/16/2014
Decision Date 05/28/2014
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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