Cleared Traditional

PM2002 PROLINE

K923534 · Planmeca USA, Inc. · Dental
Jan 1994
Decision
564d
Days
Class 1
Risk

About This 510(k) Submission

K923534 is an FDA 510(k) clearance for the PM2002 PROLINE, a Chair, Dental, With Operative Unit (Class I — General Controls, product code KLC), submitted by Planmeca USA, Inc. (Finland, FI). The FDA issued a Cleared decision on January 31, 1994, 564 days after receiving the submission on July 16, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.6250.

Submission Details

510(k) Number K923534 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 1992
Decision Date January 31, 1994
Days to Decision 564 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code KLC — Chair, Dental, With Operative Unit
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6250

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