510(k) K862039
K862039 is an FDA 510(k) premarket notification submitted by Concord Laboratories, Inc. for the device "CONCORD CARE TRAY". The FDA issued a decision of Substantially Equivalent (with conditions) on July 3, 1986. Concord Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESD (Substantially Equivalent (with conditions))
- Decision Date
- July 3, 1986
- Date Received
- May 28, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No