FDA 510(k) Application Details - K093112

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polypropylene   More FDA Info for this Device
510(K) Number	K093112
Device Name	Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant	COLOPLAST MANUFACTURING US, LLC 1601 WEST RIVER ROAD MINNEAPOLIS, MN 55411 US Other 510(k) Applications for this Company
Contact	JANELL COLLEY Other 510(k) Applications for this Contact
Regulation Number	878.5010   More FDA Info for this Regulation Number
Classification Product Code	GAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/01/2009
Decision Date	02/01/2010
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