FDA 510(k) Application Details - K010277

Device Classification Name	Anchor, Fascial   More FDA Info for this Device
510(K) Number	K010277
Device Name	Anchor, Fascial
Applicant	AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST MINNETONKA, MN 55343 US Other 510(k) Applications for this Company
Contact	ELSA LINKE Other 510(k) Applications for this Contact
Regulation Number	878.4300   More FDA Info for this Regulation Number
Classification Product Code	NEH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/30/2001
Decision Date	03/26/2001
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