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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dynamic Rectal Control System
510(k) Number K150558
Device Name Eclipse System
Applicant
Pelvalon, Inc.
923 Thompson Place
Sunnyvale,  CA  94085
Applicant Contact MILES ROSEN
Correspondent
DOMECUS CONSULTING SERVICES LLC
1171 BARROILHET DR
HILLSBOROUGH,  CA  94010
Correspondent Contact CINDY DOMECUS
Regulation Number876.5930
Classification Product Code
PJH  
Date Received03/04/2015
Decision Date 11/12/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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