510(k) K791910
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 9, 1979
- Date Received
- September 25, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bag, Reservoir
- Device Class
- Class I
- Regulation Number
- 868.5320
- Review Panel
- AN
- Submission Type