FDA 510(k) Application Details - K152951

Device Classification Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories   More FDA Info for this Device
510(K) Number	K152951
Device Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant	PARAGON MEDICAL, INC. 8 MATCHETT INDUSTRIAL PARK DRIVE PIERCETON, IN 46562 US Other 510(k) Applications for this Company
Contact	MIKE GOSMEYER 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	10/06/2015
Decision Date	12/28/2015
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	Y
Expedited Review