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FDA 510(k)

SURFACE COAT

K-Number: K063228 · 2006-12-08

ApplicantKuraray America, Inc.
Decision Date2006-12-08
Product CodeEBD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SURFACE COAT is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray America, Inc.. It received FDA 510(k) clearance on 2006-12-08 under 510(k) number K063228. The device is classified under product code EBD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURFACE COAT?

SURFACE COAT is a medical device that received FDA 510(k) clearance on 2006-12-08. The listed applicant is Kuraray America, Inc.. The 510(k) number is K063228.

When did SURFACE COAT receive FDA 510(k) clearance?

SURFACE COAT received FDA 510(k) clearance on 2006-12-08, under 510(k) number K063228.

Who is the listed applicant for SURFACE COAT?

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

What is the FDA product code for SURFACE COAT?

The FDA product code for SURFACE COAT is EBD.

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Related Devices (Code: EBD)

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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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