Cleared Traditional

RETRACTOR RODS

K891398 · Zinnanti Surgical Instruments, Inc. · Obstetrics & Gynecology
May 1989
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K891398 is an FDA 510(k) clearance for the RETRACTOR RODS, a Instrument, Manual, Specialized Obstetric-gynecologic (Class II — Special Controls, product code KNA), submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on May 11, 1989, 58 days after receiving the submission on March 14, 1989. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K891398 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 1989
Decision Date May 11, 1989
Days to Decision 58 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code KNA — Instrument, Manual, Specialized Obstetric-gynecologic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530

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