510(k) K070012
K070012 is an FDA 510(k) premarket notification submitted by Kyung Won Medical Co., Ltd. for the device "POLYBONE". The FDA issued a decision of Substantially Equivalent on December 27, 2007. The device falls under product code GXP (Methyl Methacrylate For Cranioplasty), a Class II device regulated under 21 CFR 882.5300. Kyung Won Medical Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 27, 2007
- Date Received
- January 3, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Methyl Methacrylate For Cranioplasty
- Device Class
- Class II
- Regulation Number
- 882.5300
- Review Panel
- NE
- Submission Type