510(k) K911154
K911154 is an FDA 510(k) premarket notification submitted by Sun Medical, Inc. for the device "SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200". The FDA issued a decision of Substantially Equivalent on Jul 26, 1991. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Sun Medical, Inc. has 3 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 26, 1991
- Date Received
- Mar 15, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Apparatus, Exhaust, Surgical
- Device Class
- Class II
- Regulation Number
- 878.5070
- Review Panel
- HO
- Submission Type
- 510(k)