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FDA 510(k)

REPROCESSED ENT SHAVERS

K-Number: K081814 · 2008-12-17

ApplicantSterilmed, Inc.
Decision Date2008-12-17
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

REPROCESSED ENT SHAVERS is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed, Inc.. It received FDA 510(k) clearance on 2008-12-17 under 510(k) number K081814. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPROCESSED ENT SHAVERS?

REPROCESSED ENT SHAVERS is a medical device that received FDA 510(k) clearance on 2008-12-17. The listed applicant is Sterilmed, Inc.. The 510(k) number is K081814.

When did REPROCESSED ENT SHAVERS receive FDA 510(k) clearance?

REPROCESSED ENT SHAVERS received FDA 510(k) clearance on 2008-12-17, under 510(k) number K081814.

Who is the listed applicant for REPROCESSED ENT SHAVERS?

The FDA 510(k) record lists Sterilmed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REPROCESSED ENT SHAVERS?

The FDA product code for REPROCESSED ENT SHAVERS is ERL.

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Related Devices (Code: ERL)

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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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