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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K030315
Device Name MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM
Applicant
Ultroid, LLC
2230 Damon Rd.
Carson City,  NV  89701
Applicant Contact RONALD R NEWTON
Correspondent
Ultroid, LLC
2230 Damon Rd.
Carson City,  NV  89701
Correspondent Contact RONALD R NEWTON
Regulation Number876.4300
Classification Product Code
KNS  
Date Received01/30/2003
Decision Date 02/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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