FDA 510(k) Application Details - K010990

Device Classification Name	Suture, Nonabsorbable, Synthetic, Polypropylene   More FDA Info for this Device
510(K) Number	K010990
Device Name	Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant	AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST MINNETONKA, MN 55343 US Other 510(k) Applications for this Company
Contact	ELSA A LINKE 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	04/03/2001
Decision Date	06/22/2001
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