FDA 510(k) Application Details - K102103

Device Classification Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories   More FDA Info for this Device
510(K) Number	K102103
Device Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant	SKELETAL DYNAMICS, LLC 8905 SW 87 AVENUE, SUITE 201 MIAMI, FL 33176 US Other 510(k) Applications for this Company
Contact	ANA M ESCAGEDO Other 510(k) Applications for this Contact
Regulation Number	880.6850   More FDA Info for this Regulation Number
Classification Product Code	KCT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/2010
Decision Date	12/07/2010
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