FDA 510(k) Application Details - K050355

Device Classification Name	More FDA Info for this Device
510(K) Number	K050355
Device Name	PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150
Applicant	TISSUE SCIENCE LABORATORIES, PLC 1141 CLARK STREET, SUITE D COVINGTON, GA 30014 US Other 510(k) Applications for this Company
Contact	VICTORIA TAYLOR Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PAI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/14/2005
Decision Date	03/09/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review