Steriking Packaging For Medical Devices

Wrap, Sterilization

Wipak OY

The following data is part of a premarket notification filed by Wipak Oy with the FDA for Steriking Packaging For Medical Devices.

Pre-market Notification Details

Device IDK221016
510k NumberK221016
Device Name:Steriking Packaging For Medical Devices
ClassificationWrap, Sterilization
Applicant Wipak OY Wipaktie 2 Nastola,  FI Fi-15560
ContactHanna Marttila
CorrespondentSteven T Singleton
Compliance Systems International LLC 7 Windham Hill Mendon,  NY  14506
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-05
Decision Date2022-05-05

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