REVEAL Bulk
K-Number: K171147 · 2017-08-04
ApplicantBisco, Inc.
Decision Date2017-08-04
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
REVEAL Bulk is a medical device manufactured by Bisco, Inc.. It received FDA 510(k) clearance on 2017-08-04 under approval number K171147. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the REVEAL Bulk?
REVEAL Bulk is a medical device that received FDA 510(k) clearance on 2017-08-04. It is manufactured by Bisco, Inc.. The 510(k) number is K171147.
When was REVEAL Bulk approved by the FDA?
REVEAL Bulk received FDA 510(k) clearance on 2017-08-04, under approval number K171147.
What company makes REVEAL Bulk?
REVEAL Bulk is manufactured by Bisco, Inc..
What is the FDA product code for REVEAL Bulk?
The FDA product code for REVEAL Bulk is EBF.
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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.