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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, thermal, hemorrhoids
510(k) Number K113660
Device Name COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL
Applicant
CRYOTHERAPY PRODUCTS INC.
1804 sw 81
terrace davie,  FL  33324
Applicant Contact jorge caballero
Correspondent
CRYOTHERAPY PRODUCTS INC.
1804 sw 81
terrace davie,  FL  33324
Correspodent Contact jorge caballero
Classification Product Code
LKX  
Date Received12/13/2011
Decision Date 05/03/2012
Decision substantially equivalent (SESE)
510k Review Panel Gastroenterology/Urology
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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