510(k) K914035
K914035 is an FDA 510(k) premarket notification submitted by Biomedical Composites, Ltd. for the device "MINI-MILL". The FDA issued a decision of Substantially Equivalent on March 2, 1992. The device falls under product code EMI (File, Bone, Surgical), a Class I device regulated under 21 CFR 872.4565. Biomedical Composites, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 1992
- Date Received
- September 10, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- File, Bone, Surgical
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type