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510(k) Data Aggregation
K Number
K113660Device Name
COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL
Manufacturer
CRYOTHERAPY PRODUCTS INC.
Date Cleared
2012-05-03
(142 days)
Product Code
LKX
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CRYOTHERAPY PRODUCTS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device use is the treatment of hemorrhoids by applying it directly to the swollen Hemorrhoidal tissues. By applying cold to the tissue, the inflammation is reduced. The cap section is used for the treatment of external hemorrhoids and the tube section for the treatment of internal hemorrhoids. The lubricant is used to ease the introduction of the tube into the rectum.
Device Description
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