510(k) K874401
K874401 is an FDA 510(k) premarket notification submitted by Implant Innovations International, Inc. for the device "TITANIUM SUCTION TIP". The FDA issued a decision of Substantially Equivalent on November 12, 1987. The device falls under product code EHZ (Evacuator, Oral Cavity), a Class I device regulated under 21 CFR 872.6640. Implant Innovations International, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 1987
- Date Received
- October 28, 1987
- 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