FDA 510(k) Application Details - K140127

Device Classification Name	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile   More FDA Info for this Device
510(K) Number	K140127
Device Name	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Applicant	PONTIS ORTHOPAEDICS, LLC 2299 POST STREET, SUITE 103 SAN FRANCISCO, CA 94115 US Other 510(k) Applications for this Company
Contact	LEONARD GORDON Other 510(k) Applications for this Contact
Regulation Number	878.4495   More FDA Info for this Regulation Number
Classification Product Code	GAQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/2014
Decision Date	05/28/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review