510(k) K970352
K970352 is an FDA 510(k) premarket notification submitted by Isomedix Operations, Inc. for the device "SMARTVAC SMOKE EVACUATION SYSTEM". The FDA issued a decision of Substantially Equivalent on Nov 4, 1997. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Isomedix Operations, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 4, 1997
- Date Received
- Jan 30, 1997
- 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)