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FDA 510(k)

MSCB-001

K-Number: K152274 · 2016-03-25

ApplicantGC America, Inc.
Decision Date2016-03-25
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MSCB-001 is a medical device manufactured by GC America, Inc.. It received FDA 510(k) clearance on 2016-03-25 under approval number K152274. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MSCB-001?

MSCB-001 is a medical device that received FDA 510(k) clearance on 2016-03-25. It is manufactured by GC America, Inc.. The 510(k) number is K152274.

When was MSCB-001 approved by the FDA?

MSCB-001 received FDA 510(k) clearance on 2016-03-25, under approval number K152274.

What company makes MSCB-001?

MSCB-001 is manufactured by GC America, Inc..

What is the FDA product code for MSCB-001?

The FDA product code for MSCB-001 is EIH.

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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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