510(k) K781930
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 1979
- Date Received
- November 15, 1978
- 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