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FDA 510(k)

A-SOFT RELINER

K-Number: K984483 · 1999-02-18

ApplicantS & C Polymer GmbH
Decision Date1999-02-18
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

A-SOFT 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 1999-02-18 under 510(k) number K984483. 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 A-SOFT RELINER?

A-SOFT RELINER is a medical device that received FDA 510(k) clearance on 1999-02-18. The listed applicant is S & C Polymer GmbH. The 510(k) number is K984483.

When did A-SOFT RELINER receive FDA 510(k) clearance?

A-SOFT RELINER received FDA 510(k) clearance on 1999-02-18, under 510(k) number K984483.

Who is the listed applicant for A-SOFT 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 A-SOFT RELINER?

The FDA product code for A-SOFT 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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