510(k) K874512
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 1988
- Date Received
- November 2, 1987
- 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