510(k) K864020
K864020 is an FDA 510(k) premarket notification submitted by Med-Tool, Inc. for the device "ICE PICK". The FDA issued a decision of Substantially Equivalent on October 30, 1986. Med-Tool, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 1986
- Date Received
- October 15, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No