510(k) K963839
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 1996
- Date Received
- September 24, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- Device Class
- Class I
- Regulation Number
- 878.4680
- Review Panel
- SU
- Submission Type