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FDA 510(k)

STRAUMANN GRANULES

K-Number: K040646 · 2004-05-03

ApplicantThe Straumann Co.
Decision Date2004-05-03
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STRAUMANN GRANULES is the device name listed in this FDA 510(k) record. The listed applicant is The Straumann Co.. It received FDA 510(k) clearance on 2004-05-03 under 510(k) number K040646. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRAUMANN GRANULES?

STRAUMANN GRANULES is a medical device that received FDA 510(k) clearance on 2004-05-03. The listed applicant is The Straumann Co.. The 510(k) number is K040646.

When did STRAUMANN GRANULES receive FDA 510(k) clearance?

STRAUMANN GRANULES received FDA 510(k) clearance on 2004-05-03, under 510(k) number K040646.

Who is the listed applicant for STRAUMANN GRANULES?

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

What is the FDA product code for STRAUMANN GRANULES?

The FDA product code for STRAUMANN GRANULES is LYC.

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Other records listing The Straumann Co. as applicant

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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