JAMBRO Single Core A Sterilization wrap
K-Number: K182656 · 2019-06-11
Decision Date2019-06-11
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
JAMBRO Single Core A Sterilization wrap is a medical device manufactured by Jiangsu Zhande Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2019-06-11 under approval number K182656. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the JAMBRO Single Core A Sterilization wrap?
JAMBRO Single Core A Sterilization wrap is a medical device that received FDA 510(k) clearance on 2019-06-11. It is manufactured by Jiangsu Zhande Medical Supplies Co., Ltd.. The 510(k) number is K182656.
When was JAMBRO Single Core A Sterilization wrap approved by the FDA?
JAMBRO Single Core A Sterilization wrap received FDA 510(k) clearance on 2019-06-11, under approval number K182656.
What company makes JAMBRO Single Core A Sterilization wrap?
JAMBRO Single Core A Sterilization wrap is manufactured by Jiangsu Zhande Medical Supplies Co., Ltd..
What is the FDA product code for JAMBRO Single Core A Sterilization wrap?
The FDA product code for JAMBRO Single Core A Sterilization wrap is FRG.
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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.