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FDA 510(k)

ULTRASONIC SURGICAL UNIT

K-Number: K110881 · 2011-12-16

ApplicantDong IL Technology , Ltd.
Decision Date2011-12-16
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRASONIC SURGICAL UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Dong IL Technology , Ltd.. It received FDA 510(k) clearance on 2011-12-16 under 510(k) number K110881. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASONIC SURGICAL UNIT?

ULTRASONIC SURGICAL UNIT is a medical device that received FDA 510(k) clearance on 2011-12-16. The listed applicant is Dong IL Technology , Ltd.. The 510(k) number is K110881.

When did ULTRASONIC SURGICAL UNIT receive FDA 510(k) clearance?

ULTRASONIC SURGICAL UNIT received FDA 510(k) clearance on 2011-12-16, under 510(k) number K110881.

Who is the listed applicant for ULTRASONIC SURGICAL UNIT?

The FDA 510(k) record lists Dong IL Technology , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRASONIC SURGICAL UNIT?

The FDA product code for ULTRASONIC SURGICAL UNIT is DZI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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