SteriKing LT-Blueline Pouches with Tyvek
K-Number: K221377 · 2022-12-22
ApplicantWipak OY
Decision Date2022-12-22
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 2022-12-22 under approval number K221377. 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 2022-12-22. It is manufactured by Wipak OY. The 510(k) number is K221377.
When was SteriKing LT-Blueline Pouches with Tyvek approved by the FDA?
SteriKing LT-Blueline Pouches with Tyvek received FDA 510(k) clearance on 2022-12-22, under approval number K221377.
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.