FDA 510(k) Application Details - K043591

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polypropylene   More FDA Info for this Device
510(K) Number	K043591
Device Name	Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant	KMI KOLSTER METHODS, INC. 3185 PALISADES DR. CORONA, CA 92882 US Other 510(k) Applications for this Company
Contact	KEITH DAVIS 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	12/28/2004
Decision Date	03/04/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review