COMPOUND W FREEZE OFF WART REMOVAL SYSTEM

Unit, Cryosurgical, Accessories

ORASURE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Orasure Technologies, Inc. with the FDA for Compound W Freeze Off Wart Removal System.

Pre-market Notification Details

Device IDK060859
510k NumberK060859
Device Name:COMPOUND W FREEZE OFF WART REMOVAL SYSTEM
ClassificationUnit, Cryosurgical, Accessories
Applicant ORASURE TECHNOLOGIES, INC. 150 WEBSTER ST. Bethelehem,  PA  18015 -1389
ContactSue Sutton-jones
CorrespondentSue Sutton-jones
ORASURE TECHNOLOGIES, INC. 150 WEBSTER ST. Bethelehem,  PA  18015 -1389
Product CodeGEH  
CFR Regulation Number878.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-03-28
Decision Date2006-07-18
Summary:summary

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