510(k) K870758
K870758 is an FDA 510(k) premarket notification submitted by Treace Medical, Inc. for the device "SMALL MASTOID RETRACTOR". The FDA issued a decision of Substantially Equivalent on March 4, 1987. The device falls under product code KAL (Retractor, 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
- March 4, 1987
- Date Received
- February 26, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retractor, Ent
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type