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FDA 510(k)

HYDROCOLOR 5

K-Number: K102739 · 2010-12-08

ApplicantCascades Device Consulting Associates
Decision Date2010-12-08
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HYDROCOLOR 5 is the device name listed in this FDA 510(k) record. The listed applicant is Cascades Device Consulting Associates. It received FDA 510(k) clearance on 2010-12-08 under 510(k) number K102739. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDROCOLOR 5?

HYDROCOLOR 5 is a medical device that received FDA 510(k) clearance on 2010-12-08. The listed applicant is Cascades Device Consulting Associates. The 510(k) number is K102739.

When did HYDROCOLOR 5 receive FDA 510(k) clearance?

HYDROCOLOR 5 received FDA 510(k) clearance on 2010-12-08, under 510(k) number K102739.

Who is the listed applicant for HYDROCOLOR 5?

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

What is the FDA product code for HYDROCOLOR 5?

The FDA product code for HYDROCOLOR 5 is ELW.

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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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