510(k) K915867
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- August 14, 1992
- Date Received
- December 31, 1991
- 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