510(k) K113591
K113591 is an FDA 510(k) premarket notification submitted by Fournitures Hospitalieres Industrie for the device "COLS PEEK". The FDA issued a decision of Substantially Equivalent on Dec 22, 2011. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Fournitures Hospitalieres Industrie has 23 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 22, 2011
- Date Received
- Dec 5, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
- 510(k)