Cleared Traditional

DISPOSABLE PLASTIC VAGINAL SPECULA

K894957 · Zinnanti Surgical Instruments, Inc. · Obstetrics & Gynecology
Oct 1989
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K894957 is an FDA 510(k) clearance for the DISPOSABLE PLASTIC VAGINAL SPECULA, a Speculum, Vaginal, Nonmetal (Class II — Special Controls, product code HIB), submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on October 12, 1989, 66 days after receiving the submission on August 7, 1989. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K894957 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 1989
Decision Date October 12, 1989
Days to Decision 66 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