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FDA 510(k)

BBP BONE SUBSTITUTES

K-Number: K030195 · 2004-06-17

ApplicantOct, USA, Inc.
Decision Date2004-06-17
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BBP BONE SUBSTITUTES is the device name listed in this FDA 510(k) record. The listed applicant is Oct, USA, Inc.. It received FDA 510(k) clearance on 2004-06-17 under 510(k) number K030195. 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 BBP BONE SUBSTITUTES?

BBP BONE SUBSTITUTES is a medical device that received FDA 510(k) clearance on 2004-06-17. The listed applicant is Oct, USA, Inc.. The 510(k) number is K030195.

When did BBP BONE SUBSTITUTES receive FDA 510(k) clearance?

BBP BONE SUBSTITUTES received FDA 510(k) clearance on 2004-06-17, under 510(k) number K030195.

Who is the listed applicant for BBP BONE SUBSTITUTES?

The FDA 510(k) record lists Oct, USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BBP BONE SUBSTITUTES?

The FDA product code for BBP BONE SUBSTITUTES is LYC.

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Related Devices (Code: LYC)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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