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FDA 510(k)

BIO-OSS ANORGANIC BOVINE BONE

K-Number: K970321 · 1998-09-15

ApplicantGeistlich-Pharma
Decision Date1998-09-15
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIO-OSS ANORGANIC BOVINE BONE is the device name listed in this FDA 510(k) record. The listed applicant is Geistlich-Pharma. It received FDA 510(k) clearance on 1998-09-15 under 510(k) number K970321. 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 BIO-OSS ANORGANIC BOVINE BONE?

BIO-OSS ANORGANIC BOVINE BONE is a medical device that received FDA 510(k) clearance on 1998-09-15. The listed applicant is Geistlich-Pharma. The 510(k) number is K970321.

When did BIO-OSS ANORGANIC BOVINE BONE receive FDA 510(k) clearance?

BIO-OSS ANORGANIC BOVINE BONE received FDA 510(k) clearance on 1998-09-15, under 510(k) number K970321.

Who is the listed applicant for BIO-OSS ANORGANIC BOVINE BONE?

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

What is the FDA product code for BIO-OSS ANORGANIC BOVINE BONE?

The FDA product code for BIO-OSS ANORGANIC BOVINE BONE is LYC.

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Other records listing Geistlich-Pharma 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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Related Devices (Code: LYC)

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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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