510(k) K023680
K023680 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "BIOBUCK CEMENT RESTRICTOR". The FDA issued a decision of Substantially Equivalent on November 19, 2002. The device falls under product code LZN (Cement Obturator), a Class II device regulated under 21 CFR 878.3300. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 19, 2002
- Date Received
- November 1, 2002
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cement Obturator
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- OR
- Submission Type