510(k) K823914
K823914 is an FDA 510(k) premarket notification submitted by Treace Medical, Inc. for the device "EXPLORER TIP". The FDA issued a decision of Substantially Equivalent on January 21, 1983. The device falls under product code EKB (Explorer, Operative), a Class I device regulated under 21 CFR 872.4565. Treace Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 1983
- Date Received
- December 28, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Explorer, Operative
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type