510(k) K873154
K873154 is an FDA 510(k) premarket notification submitted by Treace Medical, Inc. for the device "TREACE MAGNUM OTO-TOOL SYSTEM". The FDA issued a decision of Substantially Equivalent on September 4, 1987. The device falls under product code ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece), a Class II device regulated under 21 CFR 874.4250. Treace Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 4, 1987
- Date Received
- August 11, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- Device Class
- Class II
- Regulation Number
- 874.4250
- Review Panel
- EN
- Submission Type