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FDA 510(k)

ELUTIA COATED CLOSED SURGICAL WOUND DRAIN

K-Number: K063245 · 2007-11-28

ApplicantBacterin International, Inc.
Decision Date2007-11-28
Product CodeOEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELUTIA COATED CLOSED SURGICAL WOUND DRAIN is the device name listed in this FDA 510(k) record. The listed applicant is Bacterin International, Inc.. It received FDA 510(k) clearance on 2007-11-28 under 510(k) number K063245. The device is classified under product code OEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELUTIA COATED CLOSED SURGICAL WOUND DRAIN?

ELUTIA COATED CLOSED SURGICAL WOUND DRAIN is a medical device that received FDA 510(k) clearance on 2007-11-28. The listed applicant is Bacterin International, Inc.. The 510(k) number is K063245.

When did ELUTIA COATED CLOSED SURGICAL WOUND DRAIN receive FDA 510(k) clearance?

ELUTIA COATED CLOSED SURGICAL WOUND DRAIN received FDA 510(k) clearance on 2007-11-28, under 510(k) number K063245.

Who is the listed applicant for ELUTIA COATED CLOSED SURGICAL WOUND DRAIN?

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

What is the FDA product code for ELUTIA COATED CLOSED SURGICAL WOUND DRAIN?

The FDA product code for ELUTIA COATED CLOSED SURGICAL WOUND DRAIN is OEI.

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Official Source

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