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FDA 510(k)

PRIMAEVA MEDICAL RENESIS SYSTEM

K-Number: K082391 · 2009-09-01

ApplicantPrimaeva Medical, Inc.
Decision Date2009-09-01
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PRIMAEVA MEDICAL RENESIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Primaeva Medical, Inc.. It received FDA 510(k) clearance on 2009-09-01 under 510(k) number K082391. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMAEVA MEDICAL RENESIS SYSTEM?

PRIMAEVA MEDICAL RENESIS SYSTEM is a medical device that received FDA 510(k) clearance on 2009-09-01. The listed applicant is Primaeva Medical, Inc.. The 510(k) number is K082391.

When did PRIMAEVA MEDICAL RENESIS SYSTEM receive FDA 510(k) clearance?

PRIMAEVA MEDICAL RENESIS SYSTEM received FDA 510(k) clearance on 2009-09-01, under 510(k) number K082391.

Who is the listed applicant for PRIMAEVA MEDICAL RENESIS SYSTEM?

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

What is the FDA product code for PRIMAEVA MEDICAL RENESIS SYSTEM?

The FDA product code for PRIMAEVA MEDICAL RENESIS SYSTEM is GEI.

Related Clinical Trials

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Other records listing Primaeva Medical, Inc. 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.

K080145PRIMAEVA MEDICAL SYSTEMK072261FINESSE SYSTEM

Related Devices (Code: GEI)

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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