Cleared Traditional

PM3300 INTERMITTENT VACUUM

K944479 · Precision Medical, Inc. · General Hospital
Dec 1994
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K944479 is an FDA 510(k) clearance for the PM3300 INTERMITTENT VACUUM, a Regulator, Vacuum (Class II — Special Controls, product code KDP), submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on December 22, 1994, 100 days after receiving the submission on September 13, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K944479 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 1994
Decision Date December 22, 1994
Days to Decision 100 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code KDP — Regulator, Vacuum
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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