Cleared Traditional

IMPACT, MODEL 302

K820331 · Impact Instrumentation, Inc. · General & Plastic Surgery
Feb 1982
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K820331 is an FDA 510(k) clearance for the IMPACT, MODEL 302, a Apparatus, Suction, Ward Use, Portable, Ac-powered (Class II — Special Controls, product code JCX), submitted by Impact Instrumentation, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 23, 1982, 15 days after receiving the submission on February 8, 1982. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number K820331 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 1982
Decision Date February 23, 1982
Days to Decision 15 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code JCX — Apparatus, Suction, Ward Use, Portable, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4780

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