510(k) K870418
K870418 is an FDA 510(k) premarket notification submitted by North Coast Medi-Tek for the device "MYA-1 AND MYT-1 MYELOGRAM TRAY". The FDA issued a decision of Substantially Equivalent on March 17, 1987. North Coast Medi-Tek has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 1987
- Date Received
- February 3, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No