FDA 510(k) Application Details - K180528

Device Classification Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories   More FDA Info for this Device
510(K) Number	K180528
Device Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant	Summit Medical Inc. 815 Northwest Parkway, Suite 100 St. Paul, MN 55121 US Other 510(k) Applications for this Company
Contact	Nicole Dove 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	02/28/2018
Decision Date	11/16/2018
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