Cleared Traditional

BERKELEY V-10 VACUUM CURETTAGE SYSTEM

K030935 · Acmi Corporation · Obstetrics & Gynecology
Jun 2003
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K030935 is an FDA 510(k) clearance for the BERKELEY V-10 VACUUM CURETTAGE SYSTEM, a System, Abortion, Vacuum (Class II — Special Controls, product code HHI), submitted by Acmi Corporation (Southborough, US). The FDA issued a Cleared decision on June 23, 2003, 90 days after receiving the submission on March 25, 2003. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5070.

Submission Details

510(k) Number K030935 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 2003
Decision Date June 23, 2003
Days to Decision 90 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