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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 K052259
Device Name DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406
Applicant
Schering-Plough Healthcare Products, Inc.
3 Connell Dr.
Berkeley Heights,  NJ  07922
Applicant Contact DOREEN FRANK
Correspondent
Schering-Plough Healthcare Products, Inc.
3 Connell Dr.
Berkeley Heights,  NJ  07922
Correspondent Contact DOREEN FRANK
Regulation Number878.4350
Classification Product Code
GEH  
Date Received08/19/2005
Decision Date 12/14/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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