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FDA 510(k)

E1 ANTIOXIDANT INFUSED TECHNOLOGY

K-Number: K100048 · 2010-03-09

ApplicantBiomet Manufacturing Corp
Decision Date2010-03-09
Product CodeOIY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

E1 ANTIOXIDANT INFUSED TECHNOLOGY is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2010-03-09 under 510(k) number K100048. The device is classified under product code OIY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E1 ANTIOXIDANT INFUSED TECHNOLOGY?

E1 ANTIOXIDANT INFUSED TECHNOLOGY is a medical device that received FDA 510(k) clearance on 2010-03-09. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K100048.

When did E1 ANTIOXIDANT INFUSED TECHNOLOGY receive FDA 510(k) clearance?

E1 ANTIOXIDANT INFUSED TECHNOLOGY received FDA 510(k) clearance on 2010-03-09, under 510(k) number K100048.

Who is the listed applicant for E1 ANTIOXIDANT INFUSED TECHNOLOGY?

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

What is the FDA product code for E1 ANTIOXIDANT INFUSED TECHNOLOGY?

The FDA product code for E1 ANTIOXIDANT INFUSED TECHNOLOGY is OIY.

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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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