Steriking LT-Blueline Pouches with Tyvek
K-Number: K221379 · 2023-01-04
ApplicantWipak OY
Decision Date2023-01-04
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Steriking LT-Blueline Pouches with Tyvek is a medical device manufactured by Wipak OY. It received FDA 510(k) clearance on 2023-01-04 under approval number K221379. 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 Steriking LT-Blueline Pouches with Tyvek?
Steriking LT-Blueline Pouches with Tyvek is a medical device that received FDA 510(k) clearance on 2023-01-04. It is manufactured by Wipak OY. The 510(k) number is K221379.
When was Steriking LT-Blueline Pouches with Tyvek approved by the FDA?
Steriking LT-Blueline Pouches with Tyvek received FDA 510(k) clearance on 2023-01-04, under approval number K221379.
What company makes Steriking LT-Blueline Pouches with Tyvek?
Steriking LT-Blueline Pouches with Tyvek is manufactured by Wipak OY.
What is the FDA product code for Steriking LT-Blueline Pouches with Tyvek?
The FDA product code for Steriking LT-Blueline Pouches with Tyvek 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.