FDA 510(k) Application Details - K150327

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polyethylene   More FDA Info for this Device
510(K) Number	K150327
Device Name	Suture, Nonabsorbable, Synthetic, Polyethylene
Applicant	Dunamis LLC 693 Sherling Lake Rd. Greenville, AL 36037 US Other 510(k) Applications for this Company
Contact	Prithviraj Chavan Other 510(k) Applications for this Contact
Regulation Number	878.5000   More FDA Info for this Regulation Number
Classification Product Code	GAT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/10/2015
Decision Date	06/29/2015
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