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FDA 510(k)

MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT

K-Number: K071934 · 2007-10-11

ApplicantBiomet Manufacturing Corp
Decision Date2007-10-11
Product CodeJQC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2007-10-11 under 510(k) number K071934. The device is classified under product code JQC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT?

MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT is a medical device that received FDA 510(k) clearance on 2007-10-11. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K071934.

When did MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT receive FDA 510(k) clearance?

MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT received FDA 510(k) clearance on 2007-10-11, under 510(k) number K071934.

Who is the listed applicant for MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT?

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

What is the FDA product code for MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT?

The FDA product code for MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT is JQC.

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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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