510(k) K082338
K082338 is an FDA 510(k) premarket notification submitted by Kyung Won Medical Co., Ltd. for the device "POLYBONE GRANULE & BLOCK". The FDA issued a decision of Substantially Equivalent on October 16, 2008. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Kyung Won Medical Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 2008
- Date Received
- August 14, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filler, Bone Void, Calcium Compound
- Device Class
- Class II
- Regulation Number
- 888.3045
- Review Panel
- OR
- Submission Type