510(k) K880590
K880590 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "DISPOSABLE DENTAL PROBE/EXPLORER". The FDA issued a decision of Substantially Equivalent on Mar 2, 1988. The device falls under product code EKJ (Burnisher, Operative), a Class I device regulated under 21 CFR 872.4565. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 2, 1988
- Date Received
- Feb 11, 1988
- 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
- 510(k) Exempt