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FDA 510(k)

DSM Biomedical Calcium Phosphate Cement

K-Number: K173362 · 2018-04-03

ApplicantKensey Nash Corporation Dba Dsm Biomedical
Decision Date2018-04-03
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DSM Biomedical Calcium Phosphate Cement is the device name listed in this FDA 510(k) record. The listed applicant is Kensey Nash Corporation Dba Dsm Biomedical. It received FDA 510(k) clearance on 2018-04-03 under 510(k) number K173362. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DSM Biomedical Calcium Phosphate Cement?

DSM Biomedical Calcium Phosphate Cement is a medical device that received FDA 510(k) clearance on 2018-04-03. The listed applicant is Kensey Nash Corporation Dba Dsm Biomedical. The 510(k) number is K173362.

When did DSM Biomedical Calcium Phosphate Cement receive FDA 510(k) clearance?

DSM Biomedical Calcium Phosphate Cement received FDA 510(k) clearance on 2018-04-03, under 510(k) number K173362.

Who is the listed applicant for DSM Biomedical Calcium Phosphate Cement?

The FDA 510(k) record lists Kensey Nash Corporation Dba Dsm Biomedical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DSM Biomedical Calcium Phosphate Cement?

The FDA product code for DSM Biomedical Calcium Phosphate Cement is MQV.

Other records listing Kensey Nash Corporation Dba Dsm Biomedical 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.

K173572DSM Biomedical Calcium Phosphate Cement with MicrospheresK170245DSM Biomedical Dental Bone GraftK160474DSM Biomedical Porcine Pericardium Dental Membrane

Related Devices (Code: MQV)

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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