Sterisheet Sterilization Wrap
K-Number: K170437 · 2017-11-01
ApplicantAndersen Sterilizers, Inc.
Decision Date2017-11-01
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Sterisheet Sterilization Wrap is a medical device manufactured by Andersen Sterilizers, Inc.. It received FDA 510(k) clearance on 2017-11-01 under approval number K170437. 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 Sterisheet Sterilization Wrap?
Sterisheet Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2017-11-01. It is manufactured by Andersen Sterilizers, Inc.. The 510(k) number is K170437.
When was Sterisheet Sterilization Wrap approved by the FDA?
Sterisheet Sterilization Wrap received FDA 510(k) clearance on 2017-11-01, under approval number K170437.
What company makes Sterisheet Sterilization Wrap?
Sterisheet Sterilization Wrap is manufactured by Andersen Sterilizers, Inc..
What is the FDA product code for Sterisheet Sterilization Wrap?
The FDA product code for Sterisheet Sterilization Wrap is FRG.
Other Devices by Andersen Sterilizers, Inc.
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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.