Zipbond
K-Number: K191656 · 2019-12-02
ApplicantSdi Limited
Decision Date2019-12-02
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Zipbond is a medical device manufactured by Sdi Limited. It received FDA 510(k) clearance on 2019-12-02 under approval number K191656. 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 Zipbond?
Zipbond is a medical device that received FDA 510(k) clearance on 2019-12-02. It is manufactured by Sdi Limited. The 510(k) number is K191656.
When was Zipbond approved by the FDA?
Zipbond received FDA 510(k) clearance on 2019-12-02, under approval number K191656.
What company makes Zipbond?
Zipbond is manufactured by Sdi Limited.
What is the FDA product code for Zipbond?
The FDA product code for Zipbond 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.