510(k) K863504

OBSTETRICAL KIT by Dyna-Med

K863504 is an FDA 510(k) premarket notification submitted by Dyna-Med for the device "OBSTETRICAL KIT". The FDA issued a decision of Substantially Equivalent (with conditions) on October 22, 1986. Dyna-Med has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
October 22, 1986
Date Received
September 9, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No