FDA 510(k) Application Details - K203855

Device Classification Name	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile   More FDA Info for this Device
510(K) Number	K203855
Device Name	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Applicant	CoNextions Medical 150 North Wright Brothers Drive, Suite 560 Salt Lake City, UT 84116 US Other 510(k) Applications for this Company
Contact	Matthew Swift 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	12/31/2020
Decision Date	04/22/2022
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