Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K191522
Device Classification Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
More FDA Info for this Device
510(K) Number
K191522
Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant
Institut Straumann AG
Peter Merian-Weg 12
Basel 4002 CH
Other 510(k) Applications for this Company
Contact
Jenni Vescovo
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
06/10/2019
Decision Date
12/03/2019
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact