Cleared Traditional

OVES CERVICAL CAP

K993953 · Veos , Ltd. · Obstetrics & Gynecology
Mar 2000
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K993953 is an FDA 510(k) clearance for the OVES CERVICAL CAP, a Cap, Cervical (Class II — Special Controls, product code HDR), submitted by Veos , Ltd. (Lake Forest, US). The FDA issued a Cleared decision on March 21, 2000, 120 days after receiving the submission on November 22, 1999. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5250.

Submission Details

510(k) Number K993953 FDA.gov
FDA Decision Cleared SESU
Date Received November 22, 1999
Decision Date March 21, 2000
Days to Decision 120 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code HDR — Cap, Cervical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5250