Cleared Traditional

K840952 - MEDEVICE V-80 VACUUM PUMP
(FDA 510(k) Clearance)

K840952 · Berkeley Medevices · Obstetrics & Gynecology device

Mar 1984

Decision

25d

Days

Class 2

Risk

K840952 is an FDA 510(k) clearance for the MEDEVICE V-80 VACUUM PUMP. This device is classified as a System, Abortion, Vacuum (Class II - Special Controls, product code HHI).

Submitted by Berkeley Medevices (Walker, US). The FDA issued a Cleared decision on March 30, 1984, 25 days after receiving the submission on March 5, 1984.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5070.

Submission Details

510(k) Number	K840952 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 05, 1984
Decision Date	March 30, 1984
Days to Decision	25 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	—