510(k) K911655
K911655 is an FDA 510(k) premarket notification submitted by Implant Innovations International, Inc. for the device "IMPLARETTE". The FDA issued a decision of Substantially Equivalent on October 21, 1991. The device falls under product code EKJ (Burnisher, Operative), a Class I device regulated under 21 CFR 872.4565. Implant Innovations International, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 1991
- Date Received
- April 12, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Burnisher, Operative
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type