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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Source, Fiberoptic, Routine
510(k) Number K942155
Device Name HMT ENDOSCREEN, MODEL ESC 501
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
FCW  
Date Received05/03/1994
Decision Date 07/01/1994
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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