HAPI Seal
K-Number: K162598 · 2017-05-23
ApplicantBisco, Inc.
Decision Date2017-05-23
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
HAPI Seal is a medical device manufactured by Bisco, Inc.. It received FDA 510(k) clearance on 2017-05-23 under approval number K162598. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HAPI Seal?
HAPI Seal is a medical device that received FDA 510(k) clearance on 2017-05-23. It is manufactured by Bisco, Inc.. The 510(k) number is K162598.
When was HAPI Seal approved by the FDA?
HAPI Seal received FDA 510(k) clearance on 2017-05-23, under approval number K162598.
What company makes HAPI Seal?
HAPI Seal is manufactured by Bisco, Inc..
What is the FDA product code for HAPI Seal?
The FDA product code for HAPI Seal is EBC.
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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.