FDA 510(k) Application Details - K955338

Device Classification Name	Alarm, Conditioned Response Enuresis   More FDA Info for this Device
510(K) Number	K955338
Device Name	Alarm, Conditioned Response Enuresis
Applicant	HEALTH SENSE INTL., INC. 2057 SUMMIT DR. LAKE OSWEGO, OR 97034 US Other 510(k) Applications for this Company
Contact	ARTHUR J SAFFIR Other 510(k) Applications for this Contact
Regulation Number	876.2040   More FDA Info for this Regulation Number
Classification Product Code	KPN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/1995
Decision Date	03/12/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review