510(k) K926035
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 1992
- Date Received
- December 1, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bag, Urine Collection, Leg, For External Use, Sterile
- Device Class
- Class I
- Regulation Number
- 876.5250
- Review Panel
- GU
- Submission Type