Cleared Traditional

OP-CON SURG. INSTRUMENT #10

K834170 · Imm Enterprises , Ltd. · Neurology
Feb 1984
Decision
94d
Days
Class 1
Risk

About This 510(k) Submission

K834170 is an FDA 510(k) clearance for the OP-CON SURG. INSTRUMENT #10, a Percussor (Class I — General Controls, product code GWZ), submitted by Imm Enterprises , Ltd. (Mchenry, US). The FDA issued a Cleared decision on February 23, 1984, 94 days after receiving the submission on November 21, 1983. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1700.

Submission Details

510(k) Number K834170 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 1983
Decision Date February 23, 1984
Days to Decision 94 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code GWZ — Percussor
Device Class Class I — General Controls
CFR Regulation 21 CFR 882.1700

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