510(k) K860459
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