Cleared Traditional

LAMINARIA CUREX

K881295 · Harold W. Berger Co. · Obstetrics & Gynecology
Aug 1988
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K881295 is an FDA 510(k) clearance for the LAMINARIA CUREX, a Dilator, Cervical, Hygroscopic-laminaria (Class II — Special Controls, product code HDY), submitted by Harold W. Berger Co. (Murrieta, US). The FDA issued a Cleared decision on August 10, 1988, 135 days after receiving the submission on March 28, 1988. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4260.

Submission Details

510(k) Number K881295 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 1988
Decision Date August 10, 1988
Days to Decision 135 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