510(k) K882418
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 1988
- Date Received
- June 13, 1988
- 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