510(k) K002464
K002464 is an FDA 510(k) premarket notification submitted by Gyrus Ent LLC for the device "SMITH & NEPHEW OFF-CENTERED PORP". The FDA issued a decision of Substantially Equivalent on August 29, 2000. The device falls under product code ETB (Prosthesis, Partial Ossicular Replacement), a Class II device regulated under 21 CFR 874.3450. Gyrus Ent LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 29, 2000
- Date Received
- August 10, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Partial Ossicular Replacement
- Device Class
- Class II
- Regulation Number
- 874.3450
- Review Panel
- EN
- Submission Type