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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 K883984
Device Name HEMORX COLD PACK
Applicant
Bio-Dyne, Inc.
7720 S. W. 175th St.
Miami,  FL  33157
Applicant Contact RICHARD A CARSILLO
Correspondent
Bio-Dyne, Inc.
7720 S. W. 175th St.
Miami,  FL  33157
Correspondent Contact RICHARD A CARSILLO
Classification Product Code
LKX  
Date Received09/20/1988
Decision Date 12/22/1988
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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