WEGO-PGLA RAPID
K-Number: K183001 · 2019-01-28
ApplicantFoosin Medical Supplies Inc., Ltd.
Decision Date2019-01-28
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
WEGO-PGLA RAPID is a medical device manufactured by Foosin Medical Supplies Inc., Ltd.. It received FDA 510(k) clearance on 2019-01-28 under approval number K183001. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the WEGO-PGLA RAPID?
WEGO-PGLA RAPID is a medical device that received FDA 510(k) clearance on 2019-01-28. It is manufactured by Foosin Medical Supplies Inc., Ltd.. The 510(k) number is K183001.
When was WEGO-PGLA RAPID approved by the FDA?
WEGO-PGLA RAPID received FDA 510(k) clearance on 2019-01-28, under approval number K183001.
What company makes WEGO-PGLA RAPID?
WEGO-PGLA RAPID is manufactured by Foosin Medical Supplies Inc., Ltd..
What is the FDA product code for WEGO-PGLA RAPID?
The FDA product code for WEGO-PGLA RAPID is GAM.
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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.