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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 K031697
Device Name DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226
Applicant
Schering-Plough Healthcare Products, Inc.
3 Connell Dr.
Berkeley Heights,  NJ  07922
Applicant Contact PHILIP JOHNSON
Correspondent
Schering-Plough Healthcare Products, Inc.
3 Connell Dr.
Berkeley Heights,  NJ  07922
Correspondent Contact PHILIP JOHNSON
Regulation Number878.4350
Classification Product Code
GEH  
Date Received06/02/2003
Decision Date 08/29/2003
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 No
Predetermined Change
Control Plan Authorized		 No
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