510(k) K861164
K861164 is an FDA 510(k) premarket notification submitted by Biodynamic Technologies, Inc. for the device "OSTEOMILL BONE GRINDER". The FDA issued a decision of Substantially Equivalent on May 2, 1986. The device falls under product code LYS (Bone Mill), a Class I device regulated under 21 CFR 888.4540. Biodynamic Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 1986
- Date Received
- March 28, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bone Mill
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type