510(k) K853759
K853759 is an FDA 510(k) premarket notification submitted by Charles Atkins & Co. for the device "CUSTOM PROCEDURAL TRAY PROCEDURAL KIT". The FDA issued a decision of Substantially Equivalent (with conditions) on November 17, 1985. Charles Atkins & Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESD (Substantially Equivalent (with conditions))
- Decision Date
- November 17, 1985
- Date Received
- September 9, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No