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FDA 510(k)

ECO SUPERGEL

K-Number: K101429 · 2010-09-15

ApplicantCeracarta Spa
Decision Date2010-09-15
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECO SUPERGEL is the device name listed in this FDA 510(k) record. The listed applicant is Ceracarta Spa. It received FDA 510(k) clearance on 2010-09-15 under 510(k) number K101429. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECO SUPERGEL?

ECO SUPERGEL is a medical device that received FDA 510(k) clearance on 2010-09-15. The listed applicant is Ceracarta Spa. The 510(k) number is K101429.

When did ECO SUPERGEL receive FDA 510(k) clearance?

ECO SUPERGEL received FDA 510(k) clearance on 2010-09-15, under 510(k) number K101429.

Who is the listed applicant for ECO SUPERGEL?

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

What is the FDA product code for ECO SUPERGEL?

The FDA product code for ECO SUPERGEL is IYO.

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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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