FDA 510(k) Application Details - K002557

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polypropylene   More FDA Info for this Device
510(K) Number	K002557
Device Name	Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant	AXYA MEDICAL, INC. 100 CUMMINGS CENTER SUITE 444C BEVERLY, MA 01915 US Other 510(k) Applications for this Company
Contact	HOWARD L SCHRAYER 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	08/17/2000
Decision Date	10/06/2000
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