510(k) K082399
K082399 is an FDA 510(k) premarket notification submitted by Koros USA, Inc. for the device "PECTUS STRUT". The FDA issued a decision of Substantially Equivalent on November 5, 2009. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Koros USA, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 2009
- Date Received
- August 20, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type