CeraClean
K-Number: K163171 · 2017-04-14
ApplicantBisco, Inc.
Decision Date2017-04-14
Product CodePME
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
CeraClean is a medical device manufactured by Bisco, Inc.. It received FDA 510(k) clearance on 2017-04-14 under approval number K163171. The device is classified under product code PME. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CeraClean?
CeraClean is a medical device that received FDA 510(k) clearance on 2017-04-14. It is manufactured by Bisco, Inc.. The 510(k) number is K163171.
When was CeraClean approved by the FDA?
CeraClean received FDA 510(k) clearance on 2017-04-14, under approval number K163171.
What company makes CeraClean?
CeraClean is manufactured by Bisco, Inc..
What is the FDA product code for CeraClean?
The FDA product code for CeraClean is PME.
Other Devices by Bisco, Inc.
Related Devices (Code: PME)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.