510(k) K874512
K874512 is an FDA 510(k) premarket notification submitted by Stackhouse Assoc. for the device "MODIFIED BIOVAC:LFA LASER FUME EVACUATION SYSTEM". The FDA issued a decision of Substantially Equivalent on January 27, 1988. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Stackhouse Assoc. has at least 4 other 510(k) clearances on record.
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