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FDA 510(k)

ELAN 4 Electro Motor System Tools

K-Number: K172709 · 2018-10-17

Decision Date2018-10-17
Product CodeHBE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELAN 4 Electro Motor System Tools is a medical device manufactured by Aesculap, Inc.. It received FDA 510(k) clearance on 2018-10-17 under approval number K172709. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELAN 4 Electro Motor System Tools?

ELAN 4 Electro Motor System Tools is a medical device that received FDA 510(k) clearance on 2018-10-17. It is manufactured by Aesculap, Inc.. The 510(k) number is K172709.

When was ELAN 4 Electro Motor System Tools approved by the FDA?

ELAN 4 Electro Motor System Tools received FDA 510(k) clearance on 2018-10-17, under approval number K172709.

What company makes ELAN 4 Electro Motor System Tools?

ELAN 4 Electro Motor System Tools is manufactured by Aesculap, Inc..

What is the FDA product code for ELAN 4 Electro Motor System Tools?

The FDA product code for ELAN 4 Electro Motor System Tools is HBE.

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Official Source

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