510(k) K863854
K863854 is an FDA 510(k) premarket notification submitted by Precision Medical Devices, Inc. for the device "P.M.D. INTRAMEDULLARY CEMENT RESTRICTOR PLUG". The FDA issued a decision of Substantially Equivalent on November 19, 1986. Precision Medical Devices, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 19, 1986
- Date Received
- October 2, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No