510(k) K895251

BARD INTRAVAGINAL STIM. KIT W/(IVES(TM)) by C.R. Bard, Inc. — Product Code KPN

K895251 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD INTRAVAGINAL STIM. KIT W/(IVES(TM))". The FDA issued a decision of Substantially Equivalent on November 13, 1989. The device falls under product code KPN (Alarm, Conditioned Response Enuresis), a Class II device regulated under 21 CFR 876.2040. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1989
Date Received
August 21, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alarm, Conditioned Response Enuresis
Device Class
Class II
Regulation Number
876.2040
Review Panel
GU
Submission Type