510(k) K033395
K033395 is an FDA 510(k) premarket notification submitted by Codman & Shurtleff, Inc. for the device "CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1". The FDA issued a decision of Substantially Equivalent on February 25, 2004. The device falls under product code GXO (Strip, Craniosynostosis, Preformed), a Class II device regulated under 21 CFR 882.5900. Codman & Shurtleff, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 2004
- Date Received
- October 23, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Strip, Craniosynostosis, Preformed
- Device Class
- Class II
- Regulation Number
- 882.5900
- Review Panel
- NE
- Submission Type