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FDA 510(k)

COMPOUND W FREEZE OFF WART REMOVAL SYSTEM

K-Number: K060859 · 2006-07-18

ApplicantOraSure Technologies, Inc.
Decision Date2006-07-18
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COMPOUND W FREEZE OFF WART REMOVAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is OraSure Technologies, Inc.. It received FDA 510(k) clearance on 2006-07-18 under 510(k) number K060859. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPOUND W FREEZE OFF WART REMOVAL SYSTEM?

COMPOUND W FREEZE OFF WART REMOVAL SYSTEM is a medical device that received FDA 510(k) clearance on 2006-07-18. The listed applicant is OraSure Technologies, Inc.. The 510(k) number is K060859.

When did COMPOUND W FREEZE OFF WART REMOVAL SYSTEM receive FDA 510(k) clearance?

COMPOUND W FREEZE OFF WART REMOVAL SYSTEM received FDA 510(k) clearance on 2006-07-18, under 510(k) number K060859.

Who is the listed applicant for COMPOUND W FREEZE OFF WART REMOVAL SYSTEM?

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

What is the FDA product code for COMPOUND W FREEZE OFF WART REMOVAL SYSTEM?

The FDA product code for COMPOUND W FREEZE OFF WART REMOVAL SYSTEM is GEH.

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Other records listing OraSure Technologies, Inc. as applicant

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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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