Cleared Traditional

NEWPORT LATERAL VAGINAL RETRACTOR

K891351 · Simpson/Basye, Inc. · Obstetrics & Gynecology
May 1989
Decision
62d
Days
Class 1
Risk

About This 510(k) Submission

K891351 is an FDA 510(k) clearance for the NEWPORT LATERAL VAGINAL RETRACTOR, a Instrument, Manual, General Obstetric-gynecologic (Class I — General Controls, product code KOH), submitted by Simpson/Basye, Inc. (Wilmington, US). The FDA issued a Cleared decision on May 11, 1989, 62 days after receiving the submission on March 10, 1989. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4520.

Submission Details

510(k) Number K891351 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 1989
Decision Date May 11, 1989
Days to Decision 62 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code KOH — Instrument, Manual, General Obstetric-gynecologic
Device Class Class I — General Controls
CFR Regulation 21 CFR 884.4520

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