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510(k) Data Aggregation
K Number
K052259Device Name
DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406
Manufacturer
SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC.
Date Cleared
2005-12-14
(117 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dr. Scholl's® Dual Action Freeze Away™ Wart Remover is indicated for the overthe-counter removal of common and plantar warts.
For the removal of common and plantar warts.
Device Description
Dr. Scholl's® Dual Action Freeze Away™ Wart Remover is a cryosurgical system for the over-the-counter removal of common and plantar warts. The device consists of the following:
a. Pressurized canister with a cryogen mixture of liquid dimethyl ether and propane
b. Salicylic Acid Liquid Wart Remover
c. Reusable activator that releases the cryogen into the applicators
d. Disposable applicators
e. Cushions
f. Information booklet
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K Number
K031697Device Name
DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226
Manufacturer
SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC.
Date Cleared
2003-08-29
(88 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the over-the-counter removal of common warts and plantar warts on the bottom of the foot.
Device Description
Dr. Scholl's Freeze Away Wart Remover is a cryosurgical system for the over-thecounter removal of common warts and plantar warts on the bottom of the foot. The device consists of the following:
- Pressurized canister with a cryogen mixture of liquid dimethyl ether and propane
- Reusable activator that releases the cryogen into the applicators
- Disposable applicators
- Information booklet
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