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FDA 510(k)

CONTRALCO

K-Number: K100879 · 2010-08-04

ApplicantContralco
Decision Date2010-08-04
Product CodeDJZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CONTRALCO is the device name listed in this FDA 510(k) record. The listed applicant is Contralco. It received FDA 510(k) clearance on 2010-08-04 under 510(k) number K100879. The device is classified under product code DJZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTRALCO?

CONTRALCO is a medical device that received FDA 510(k) clearance on 2010-08-04. The listed applicant is Contralco. The 510(k) number is K100879.

When did CONTRALCO receive FDA 510(k) clearance?

CONTRALCO received FDA 510(k) clearance on 2010-08-04, under 510(k) number K100879.

Who is the listed applicant for CONTRALCO?

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

What is the FDA product code for CONTRALCO?

The FDA product code for CONTRALCO is DJZ.

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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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