510(k) K864621
K864621 is an FDA 510(k) premarket notification submitted by Seldoren , Ltd. for the device "VAC - RITE RIGHT ANGLE ASPIRATOR TUBE & HOLDER". The FDA issued a decision of Substantially Equivalent on February 13, 1987. The device falls under product code EHZ (Evacuator, Oral Cavity), a Class I device regulated under 21 CFR 872.6640.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 1987
- Date Received
- November 24, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Evacuator, Oral Cavity
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type