Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact