Straumann Sterile Healing Solution
K-Number: K161677 · 2016-10-07
ApplicantInstitut Straumann AG
Decision Date2016-10-07
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Straumann Sterile Healing Solution is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2016-10-07 under approval number K161677. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Straumann Sterile Healing Solution?
Straumann Sterile Healing Solution is a medical device that received FDA 510(k) clearance on 2016-10-07. It is manufactured by Institut Straumann AG. The 510(k) number is K161677.
When was Straumann Sterile Healing Solution approved by the FDA?
Straumann Sterile Healing Solution received FDA 510(k) clearance on 2016-10-07, under approval number K161677.
What company makes Straumann Sterile Healing Solution?
Straumann Sterile Healing Solution is manufactured by Institut Straumann AG.
What is the FDA product code for Straumann Sterile Healing Solution?
The FDA product code for Straumann Sterile Healing Solution is NHA.
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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.