Cleared Special

COMPOUND W FREEZE OFF WART REMOVAL SYSTEM

K060859 · OraSure Technologies, Inc. · General & Plastic Surgery
Jul 2006
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K060859 is an FDA 510(k) clearance for the COMPOUND W FREEZE OFF WART REMOVAL SYSTEM, a Unit, Cryosurgical, Accessories (Class II — Special Controls, product code GEH), submitted by OraSure Technologies, Inc. (Bethelehem, US). The FDA issued a Cleared decision on July 18, 2006, 112 days after receiving the submission on March 28, 2006. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.

Submission Details

510(k) Number K060859 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2006
Decision Date July 18, 2006
Days to Decision 112 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GEH — Unit, Cryosurgical, Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4350

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