Extremely Thin 003, ZERO ZERO THREE
K-Number: K192669 · 2020-07-24
ApplicantOkamoto USA, Inc.
Decision Date2020-07-24
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Extremely Thin 003, ZERO ZERO THREE is a medical device manufactured by Okamoto USA, Inc.. It received FDA 510(k) clearance on 2020-07-24 under approval number K192669. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Extremely Thin 003, ZERO ZERO THREE?
Extremely Thin 003, ZERO ZERO THREE is a medical device that received FDA 510(k) clearance on 2020-07-24. It is manufactured by Okamoto USA, Inc.. The 510(k) number is K192669.
When was Extremely Thin 003, ZERO ZERO THREE approved by the FDA?
Extremely Thin 003, ZERO ZERO THREE received FDA 510(k) clearance on 2020-07-24, under approval number K192669.
What company makes Extremely Thin 003, ZERO ZERO THREE?
Extremely Thin 003, ZERO ZERO THREE is manufactured by Okamoto USA, Inc..
What is the FDA product code for Extremely Thin 003, ZERO ZERO THREE?
The FDA product code for Extremely Thin 003, ZERO ZERO THREE is HIS.
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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.