Cleared Traditional

GYNECOLOGIC EXAMINATION KIT

K894489 · A & A Medical, Inc. · Obstetrics & Gynecology
Oct 1989
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K894489 is an FDA 510(k) clearance for the GYNECOLOGIC EXAMINATION KIT, a Speculum, Vaginal, Nonmetal (Class II — Special Controls, product code HIB), submitted by A & A Medical, Inc. (Branford, US). The FDA issued a Cleared decision on October 5, 1989, 77 days after receiving the submission on July 20, 1989. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K894489 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 1989
Decision Date October 05, 1989
Days to Decision 77 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code HIB — Speculum, Vaginal, Nonmetal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530