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FDA 510(k)

REPLAM HYDROXYAPATATITE

K-Number: K822420 · 1982-09-28

ApplicantReplam Corp.
Decision Date1982-09-28
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

REPLAM HYDROXYAPATATITE is the device name listed in this FDA 510(k) record. The listed applicant is Replam Corp.. It received FDA 510(k) clearance on 1982-09-28 under 510(k) number K822420. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPLAM HYDROXYAPATATITE?

REPLAM HYDROXYAPATATITE is a medical device that received FDA 510(k) clearance on 1982-09-28. The listed applicant is Replam Corp.. The 510(k) number is K822420.

When did REPLAM HYDROXYAPATATITE receive FDA 510(k) clearance?

REPLAM HYDROXYAPATATITE received FDA 510(k) clearance on 1982-09-28, under 510(k) number K822420.

Who is the listed applicant for REPLAM HYDROXYAPATATITE?

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

What is the FDA product code for REPLAM HYDROXYAPATATITE?

The FDA product code for REPLAM HYDROXYAPATATITE is FMF.

Related Clinical Trials

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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Other records listing Replam Corp. 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.

K830304REPLAM HYDROXYAPATITE

Related Devices (Code: FMF)

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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