FDA 510(k)

KETTOSIL AND SILGINAT

K-Number: K082157 · 2008-08-06

Decision Date2008-08-06

Product CodeELW

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

KETTOSIL AND SILGINAT 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 2008-08-06 under 510(k) number K082157. 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 KETTOSIL AND SILGINAT?

KETTOSIL AND SILGINAT is a medical device that received FDA 510(k) clearance on 2008-08-06. The listed applicant is Kettenbach GmbH & Co. KG. The 510(k) number is K082157.

When did KETTOSIL AND SILGINAT receive FDA 510(k) clearance?

KETTOSIL AND SILGINAT received FDA 510(k) clearance on 2008-08-06, under 510(k) number K082157.

Who is the listed applicant for KETTOSIL AND SILGINAT?

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 KETTOSIL AND SILGINAT?

The FDA product code for KETTOSIL AND SILGINAT is ELW.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.