Cleared Traditional

MATRX MEDICAL MAXIMIZER 1000 AND 2000 VACUUM PUMP

K915353 · Matrix Medica, Inc. · Dental
Dec 1991
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K915353 is an FDA 510(k) clearance for the MATRX MEDICAL MAXIMIZER 1000 AND 2000 VACUUM PUMP, a Unit, Operative Dental (Class I — General Controls, product code EIA), submitted by Matrix Medica, Inc. (Orchard Park, US). The FDA issued a Cleared decision on December 27, 1991, 31 days after receiving the submission on November 26, 1991. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number K915353 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 1991
Decision Date December 27, 1991
Days to Decision 31 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EIA — Unit, Operative Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6640

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