Cleared Traditional

NEUROLOGICAL RONGEURS - VARIOUS TYPES

K892535 · Zinnanti Surgical Instruments, Inc. · Neurology
May 1989
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K892535 is an FDA 510(k) clearance for the NEUROLOGICAL RONGEURS - VARIOUS TYPES, a Rongeur, Manual (Class II — Special Controls, product code HAE), submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on May 11, 1989, 30 days after receiving the submission on April 11, 1989. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4840.

Submission Details

510(k) Number K892535 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1989
Decision Date May 11, 1989
Days to Decision 30 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code HAE — Rongeur, Manual
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4840