510(k) K971749
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 1998
- Date Received
- May 12, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Portable, Aspiration (Manual Or Powered)
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type