510(k) K003214
K003214 is an FDA 510(k) premarket notification submitted by Gyrus Ent LLC for the device "SMITH & NEPHEW PISTONS". The FDA issued a decision of Substantially Equivalent on October 31, 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
- October 31, 2000
- Date Received
- October 13, 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