Cleared Traditional

IMPACT, MODELS 306/307

K820338 · Impact Instrumentation, Inc. · General & Plastic Surgery
Mar 1982
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K820338 is an FDA 510(k) clearance for the IMPACT, MODELS 306/307, a Pump, Portable, Aspiration (manual Or Powered) (Class II — Special Controls, product code BTA), 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 & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number K820338 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 & Plastic Surgery (SU)
Summary —

Device Classification

Product Code BTA — Pump, Portable, Aspiration (manual Or Powered)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4780

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