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FDA 510(k)

OSTEOGRAF 2040 OSTEOGRAF 4060

K-Number: K852199 · 1985-10-07

ApplicantOsteotech, Inc.
Decision Date1985-10-07
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEOGRAF 2040 OSTEOGRAF 4060 is the device name listed in this FDA 510(k) record. The listed applicant is Osteotech, Inc.. It received FDA 510(k) clearance on 1985-10-07 under 510(k) number K852199. 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 OSTEOGRAF 2040 OSTEOGRAF 4060?

OSTEOGRAF 2040 OSTEOGRAF 4060 is a medical device that received FDA 510(k) clearance on 1985-10-07. The listed applicant is Osteotech, Inc.. The 510(k) number is K852199.

When did OSTEOGRAF 2040 OSTEOGRAF 4060 receive FDA 510(k) clearance?

OSTEOGRAF 2040 OSTEOGRAF 4060 received FDA 510(k) clearance on 1985-10-07, under 510(k) number K852199.

Who is the listed applicant for OSTEOGRAF 2040 OSTEOGRAF 4060?

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

What is the FDA product code for OSTEOGRAF 2040 OSTEOGRAF 4060?

The FDA product code for OSTEOGRAF 2040 OSTEOGRAF 4060 is LYC.

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Other records listing Osteotech, Inc. as applicant

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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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