FDA 510(k) Application Details - K093649

Device Classification Name	Wrap, Sterilization   More FDA Info for this Device
510(K) Number	K093649
Device Name	Wrap, Sterilization
Applicant	AESCULAP 3773 CORPORATE PKWY. CENTER VALLEY, PA 18034 US Other 510(k) Applications for this Company
Contact	KATHY RACOSKY Other 510(k) Applications for this Contact
Regulation Number	880.6850   More FDA Info for this Regulation Number
Classification Product Code	FRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/25/2009
Decision Date	05/11/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review