Cleared Traditional

K863504 - OBSTETRICAL KIT
(FDA 510(k) Clearance)

K863504 · Dyna-Med · Obstetrics & Gynecology device
Oct 1986
Decision
43d
Days
—
Risk

K863504 is an FDA 510(k) clearance for the OBSTETRICAL KIT..

Submitted by Dyna-Med (Brewster, US). The FDA issued a Cleared decision on October 22, 1986, 43 days after receiving the submission on September 9, 1986.

This device falls under the Obstetrics & Gynecology FDA review panel.

Submission Details

510(k) Number K863504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received September 09, 1986
Decision Date October 22, 1986
Days to Decision 43 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code —
Device Class —