All-Bond Universal w/BAC (not finalized)
K-Number: K161051 · 2016-09-09
ApplicantBisco, Inc.
Decision Date2016-09-09
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
All-Bond Universal w/BAC (not finalized) is a medical device manufactured by Bisco, Inc.. It received FDA 510(k) clearance on 2016-09-09 under approval number K161051. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the All-Bond Universal w/BAC (not finalized)?
All-Bond Universal w/BAC (not finalized) is a medical device that received FDA 510(k) clearance on 2016-09-09. It is manufactured by Bisco, Inc.. The 510(k) number is K161051.
When was All-Bond Universal w/BAC (not finalized) approved by the FDA?
All-Bond Universal w/BAC (not finalized) received FDA 510(k) clearance on 2016-09-09, under approval number K161051.
What company makes All-Bond Universal w/BAC (not finalized)?
All-Bond Universal w/BAC (not finalized) is manufactured by Bisco, Inc..
What is the FDA product code for All-Bond Universal w/BAC (not finalized)?
The FDA product code for All-Bond Universal w/BAC (not finalized) is KLE.
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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.