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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Institut Straumann AG. It received FDA 510(k) clearance on 2016-10-07 under 510(k) 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. The listed applicant is Institut Straumann AG. The 510(k) number is K161677.

When did Straumann Sterile Healing Solution receive FDA 510(k) clearance?

Straumann Sterile Healing Solution received FDA 510(k) clearance on 2016-10-07, under 510(k) number K161677.

Who is the listed applicant for Straumann Sterile Healing Solution?

The FDA 510(k) record lists Institut Straumann AG as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: NHA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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