510(k) K882349
K882349 is an FDA 510(k) premarket notification submitted by Treace Medical, Inc. for the device "MALLET, SURGICAL". The FDA issued a decision of Substantially Equivalent on June 23, 1988. The device falls under product code HXL (Mallet), a Class I device regulated under 21 CFR 878.4800. Treace Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 1988
- Date Received
- June 7, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mallet
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type