FDA 510(k) Application Details - K013059

Device Classification Name	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile   More FDA Info for this Device
510(K) Number	K013059
Device Name	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Applicant	STONY BROOK SURGICAL INNOVATIONS, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 US Other 510(k) Applications for this Company
Contact	SUSAN D GOLDSTEIN-FALK Other 510(k) Applications for this Contact
Regulation Number	878.4495   More FDA Info for this Regulation Number
Classification Product Code	GAQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/11/2001
Decision Date	10/22/2001
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