Cleared Traditional

K901442 - BAXTER D & C TRAY
(FDA 510(k) Clearance)

K901442 · Baxter Healthcare Corp · Obstetrics & Gynecology device

Jul 1990

Decision

121d

Days

Class 1

Risk

K901442 is an FDA 510(k) clearance for the BAXTER D & C TRAY. This device is classified as a Curette, Uterine (Class I - General Controls, product code HCY).

Submitted by Baxter Healthcare Corp (Niles, US). The FDA issued a Cleared decision on July 26, 1990, 121 days after receiving the submission on March 27, 1990.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K901442 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 27, 1990
Decision Date	July 26, 1990
Days to Decision	121 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	—