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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, cryosurgical, accessories
510(k) Number K060859
Device Name COMPOUND W FREEZE OFF WART REMOVAL SYSTEM
Applicant
ORASURE TECHNOLOGIES, INC.
150 WEBSTER ST.
BETHELEHEM,  PA  18015 -1389
Applicant Contact SUE SUTTON-JONES
Correspondent
ORASURE TECHNOLOGIES, INC.
150 WEBSTER ST.
BETHELEHEM,  PA  18015 -1389
Correspondent Contact SUE SUTTON-JONES
Regulation Number878.4350
Classification Product Code
GEH  
Date Received03/28/2006
Decision Date 07/18/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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