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FDA 510(k)

OPACIDEN SOLUTION

K-Number: K070627 · 2007-08-02

ApplicantCiden Technologies, LLC
Decision Date2007-08-02
Product CodeMED
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OPACIDEN SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Ciden Technologies, LLC. It received FDA 510(k) clearance on 2007-08-02 under 510(k) number K070627. The device is classified under product code MED. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPACIDEN SOLUTION?

OPACIDEN SOLUTION is a medical device that received FDA 510(k) clearance on 2007-08-02. The listed applicant is Ciden Technologies, LLC. The 510(k) number is K070627.

When did OPACIDEN SOLUTION receive FDA 510(k) clearance?

OPACIDEN SOLUTION received FDA 510(k) clearance on 2007-08-02, under 510(k) number K070627.

Who is the listed applicant for OPACIDEN SOLUTION?

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

What is the FDA product code for OPACIDEN SOLUTION?

The FDA product code for OPACIDEN SOLUTION is MED.

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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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