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FDA 510(k)

PANASIL INITIAL CONTACT AND PANASIL TRAY

K-Number: K083701 · 2009-01-09

ApplicantKettenbach GmbH & Co. KG
Decision Date2009-01-09
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PANASIL INITIAL CONTACT AND PANASIL TRAY 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 2009-01-09 under 510(k) number K083701. 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 PANASIL INITIAL CONTACT AND PANASIL TRAY?

PANASIL INITIAL CONTACT AND PANASIL TRAY is a medical device that received FDA 510(k) clearance on 2009-01-09. The listed applicant is Kettenbach GmbH & Co. KG. The 510(k) number is K083701.

When did PANASIL INITIAL CONTACT AND PANASIL TRAY receive FDA 510(k) clearance?

PANASIL INITIAL CONTACT AND PANASIL TRAY received FDA 510(k) clearance on 2009-01-09, under 510(k) number K083701.

Who is the listed applicant for PANASIL INITIAL CONTACT AND PANASIL TRAY?

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 PANASIL INITIAL CONTACT AND PANASIL TRAY?

The FDA product code for PANASIL INITIAL CONTACT AND PANASIL TRAY 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.

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