Cleared Traditional

VABRA ASPIRATOR

K800833 · Cooper Medical Devices Corp. · Obstetrics & Gynecology
May 1980
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K800833 is an FDA 510(k) clearance for the VABRA ASPIRATOR, a System, Abortion, Vacuum (Class II — Special Controls, product code HHI), submitted by Cooper Medical Devices Corp. (Mchenry, US). The FDA issued a Cleared decision on May 14, 1980, 30 days after receiving the submission on April 14, 1980. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5070.

Submission Details

510(k) Number K800833 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 1980
Decision Date May 14, 1980
Days to Decision 30 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

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