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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 K822649
Device Name DEVICE FOR THE TREATMENT OF HEMORRHOIDS
Applicant
Dunmore Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Dunmore Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Classification Product Code
LKX  
Date Received09/01/1982
Decision Date 11/03/1982
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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