FDA 510(k) Application Details - K180701

Device Classification Name	Suture, Nonabsorbable, Silk   More FDA Info for this Device
510(K) Number	K180701
Device Name	Suture, Nonabsorbable, Silk
Applicant	SafePath Medical, Inc. 21 Water Street - 5th Floor Amesbury, MA 01913 US Other 510(k) Applications for this Company
Contact	Howard L. Schrayer Other 510(k) Applications for this Contact
Regulation Number	878.5030   More FDA Info for this Regulation Number
Classification Product Code	GAP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2018
Decision Date	06/25/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review