510(k) K860459

UNITY DISPOSABLE INCONTINENT BRIEF by Bevan Medical, Inc. — Product Code EYQ

K860459 is an FDA 510(k) premarket notification submitted by Bevan Medical, Inc. for the device "UNITY DISPOSABLE INCONTINENT BRIEF". The FDA issued a decision of Substantially Equivalent on February 26, 1986. The device falls under product code EYQ (Garment, Protective, For Incontinence), a Class I device regulated under 21 CFR 876.5920. Bevan Medical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1986
Date Received
February 6, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Garment, Protective, For Incontinence
Device Class
Class I
Regulation Number
876.5920
Review Panel
GU
Submission Type