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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 K862757
Device Name STARCHILD SLEEPDRY
Applicant
Starchild, Inc.
237 Lake Ct.
Aptos,  CA  95003
Applicant Contact STEVE MCQUILLIAMS
Correspondent
Starchild, Inc.
237 Lake Ct.
Aptos,  CA  95003
Correspondent Contact STEVE MCQUILLIAMS
Regulation Number876.2040
Classification Product Code
KPN  
Date Received07/22/1986
Decision Date 10/29/1986
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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