Cleared Traditional

IMPACT, MODEL 303

K820337 · Impact Instrumentation, Inc. · General Hospital
Mar 1982
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K820337 is an FDA 510(k) clearance for the IMPACT, MODEL 303, a Apparatus, Suction, Operating-room, Wall Vacuum Powered (Class II — Special Controls, product code GCX), submitted by Impact Instrumentation, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 2, 1982, 22 days after receiving the submission on February 8, 1982. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K820337 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 1982
Decision Date March 02, 1982
Days to Decision 22 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code GCX — Apparatus, Suction, Operating-room, Wall Vacuum Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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