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FDA 510(k)

MAMMOSITE MULTI LUMEN

K-Number: K092405 · 2009-08-27

ApplicantHologic, Inc.
Decision Date2009-08-27
Product CodeJAQ
Advisory CommitteeRA
DecisionUnknown

Device Summary

MAMMOSITE MULTI LUMEN is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2009-08-27 under 510(k) number K092405. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the MAMMOSITE MULTI LUMEN?

MAMMOSITE MULTI LUMEN is a medical device that received FDA 510(k) clearance on 2009-08-27. The listed applicant is Hologic, Inc.. The 510(k) number is K092405.

When did MAMMOSITE MULTI LUMEN receive FDA 510(k) clearance?

MAMMOSITE MULTI LUMEN received FDA 510(k) clearance on 2009-08-27, under 510(k) number K092405.

Who is the listed applicant for MAMMOSITE MULTI LUMEN?

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

What is the FDA product code for MAMMOSITE MULTI LUMEN?

The FDA product code for MAMMOSITE MULTI LUMEN is JAQ.

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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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