Cleared Traditional

K892220 - LAMINARIA TENT
(FDA 510(k) Clearance)

K892220 · Berkeley Medevices · Obstetrics & Gynecology
Jun 1989
Decision
72d
Days
Class 2
Risk

K892220 is an FDA 510(k) clearance for the LAMINARIA TENT, a Dilator, Cervical, Hygroscopic-laminaria (Class II — Special Controls, product code HDY), submitted by Berkeley Medevices (Berkeley, US). The FDA issued a Cleared decision on June 14, 1989, 72 days after receiving the submission on April 3, 1989. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4260.

Submission Details

510(k) Number K892220 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 1989
Decision Date June 14, 1989
Days to Decision 72 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code HDY — Dilator, Cervical, Hygroscopic-laminaria
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4260