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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ureteroscope And Accessories, Flexible/Rigid
510(k) Number K941013
Device Name HMT ALEXCOPE
Applicant
Servicetrends, Inc.
2130 Barrett Park Dr. NE,
Suite 103
Kennesaw,  GA  30144
Applicant Contact JOHN WARLICK
Correspondent
Servicetrends, Inc.
2130 Barrett Park Dr. NE,
Suite 103
Kennesaw,  GA  30144
Correspondent Contact JOHN WARLICK
Regulation Number876.1500
Classification Product Code
FGB  
Date Received03/03/1994
Decision Date 02/09/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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