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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alarm, Conditioned Response Enuresis
510(k) Number K130951
Device Name SIM
Applicant
Simavita Pty Limited
555 13th St., NW
Washington,  DC  20004
Applicant Contact JOHN J SMITH, MD,JD
Correspondent
Simavita Pty Limited
555 13th St., NW
Washington,  DC  20004
Correspondent Contact JOHN J SMITH, MD,JD
Regulation Number876.2040
Classification Product Code
KPN  
Date Received04/05/2013
Decision Date 08/22/2013
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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