Cleared Traditional

MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER

K931205 · Baxter Healthcare Corp · Obstetrics & Gynecology
Mar 1994
Decision
371d
Days
Class 2
Risk

About This 510(k) Submission

K931205 is an FDA 510(k) clearance for the MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER, a System, Abortion, Vacuum (Class II — Special Controls, product code HHI), submitted by Baxter Healthcare Corp (Deerfield, US). The FDA issued a Cleared decision on March 15, 1994, 371 days after receiving the submission on March 9, 1993. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5070.

Submission Details

510(k) Number K931205 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 1993
Decision Date March 15, 1994
Days to Decision 371 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HHI — System, Abortion, Vacuum
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5070