510(k) K841356
K841356 is an FDA 510(k) premarket notification submitted by Treace Medical, Inc. for the device "ELEVATOR". The FDA issued a decision of Substantially Equivalent on July 18, 1984. The device falls under product code KAD (Elevator, Ent), a Class I device regulated under 21 CFR 874.4420. Treace Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 1984
- Date Received
- April 2, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Elevator, Ent
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type