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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 K855150
Device Name HPK-A DEVICE DFOR THE TREATMENT OF HEMORRHOIDS
Applicant
Hpk International, Inc.
600 New Hampshire Ave., NW,
Suite 720
Washington,  DC  20037
Applicant Contact ANTHONY ROCCOGRANDI
Correspondent
Hpk International, Inc.
600 New Hampshire Ave., NW,
Suite 720
Washington,  DC  20037
Correspondent Contact ANTHONY ROCCOGRANDI
Classification Product Code
LKX  
Date Received12/26/1985
Decision Date 04/01/1986
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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