Cleared Traditional

TEFLON UTERINE SOUND

K870550 · Cook Ob/Gyn · Obstetrics & Gynecology
Mar 1987
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K870550 is an FDA 510(k) clearance for the TEFLON UTERINE SOUND, a Sound, Uterine (Class I — General Controls, product code HHM), submitted by Cook Ob/Gyn (Bloomington, US). The FDA issued a Cleared decision on March 4, 1987, 22 days after receiving the submission on February 10, 1987. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K870550 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 1987
Decision Date March 04, 1987
Days to Decision 22 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code HHM — Sound, Uterine
Device Class Class I — General Controls
CFR Regulation 21 CFR 884.4530