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FDA 510(k)

CONCAVE RN HEALING CAP

K-Number: K081186 · 2008-05-23

ApplicantInstitut Straumann AG
Decision Date2008-05-23
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CONCAVE RN HEALING CAP 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 2008-05-23 under 510(k) number K081186. 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 CONCAVE RN HEALING CAP?

CONCAVE RN HEALING CAP is a medical device that received FDA 510(k) clearance on 2008-05-23. The listed applicant is Institut Straumann AG. The 510(k) number is K081186.

When did CONCAVE RN HEALING CAP receive FDA 510(k) clearance?

CONCAVE RN HEALING CAP received FDA 510(k) clearance on 2008-05-23, under 510(k) number K081186.

Who is the listed applicant for CONCAVE RN HEALING CAP?

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 CONCAVE RN HEALING CAP?

The FDA product code for CONCAVE RN HEALING CAP 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.

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