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FDA 510(k)

HARD RELINER

K-Number: K011277 · 2001-06-26

ApplicantS & C Polymer GmbH
Decision Date2001-06-26
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HARD RELINER is the device name listed in this FDA 510(k) record. The listed applicant is S & C Polymer GmbH. It received FDA 510(k) clearance on 2001-06-26 under 510(k) number K011277. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HARD RELINER?

HARD RELINER is a medical device that received FDA 510(k) clearance on 2001-06-26. The listed applicant is S & C Polymer GmbH. The 510(k) number is K011277.

When did HARD RELINER receive FDA 510(k) clearance?

HARD RELINER received FDA 510(k) clearance on 2001-06-26, under 510(k) number K011277.

Who is the listed applicant for HARD RELINER?

The FDA 510(k) record lists S & C Polymer GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HARD RELINER?

The FDA product code for HARD RELINER is EBI.

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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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