FDA 510(k)

IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT

K-Number: K092867 · 2009-10-01

Decision Date2009-10-01

Product CodeELW

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Kettenbach GmbH & Co. KG. It received FDA 510(k) clearance on 2009-10-01 under 510(k) number K092867. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT?

IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT is a medical device that received FDA 510(k) clearance on 2009-10-01. The listed applicant is Kettenbach GmbH & Co. KG. The 510(k) number is K092867.

When did IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT receive FDA 510(k) clearance?

IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT received FDA 510(k) clearance on 2009-10-01, under 510(k) number K092867.

Who is the listed applicant for IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT?

The FDA 510(k) record lists Kettenbach GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT?

The FDA product code for IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT is ELW.

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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.