FDA 510(k) Application Details - K191475

Device Classification Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories   More FDA Info for this Device
510(K) Number	K191475
Device Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant	Nobel Biocare AB BOX 5190, SE-402 26, Vastra Hamngatan 1 Goteborg SE-411 17 SE Other 510(k) Applications for this Company
Contact	Charlemagne Chua 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	06/04/2019
Decision Date	08/29/2019
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