PM2002 PROLINE— 510(k) K923534

Substantially Equivalent

Planmeca USA, Inc.

FDA 510(k) clearance K923534 for PM2002 PROLINE, Substantially Equivalent on 1994-01-31. Applicant: Planmeca USA, Inc.. Device class: 1.

Clearance details

Applicant: Planmeca USA, Inc.
Product code: Code KLC
Device class: Class 1
Regulation: 21 CFR 872.6250
Advisory panel: Dental
Date received: 1992-07-16
Decision date: 1994-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Finland, FI

Download summary PDF View on FDA.gov ↗

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More clearances from Planmeca USA, Inc.

K111361 — PLANMED NUANCE EXCEL2011-09-23
K081699 — PLANMECA SOVEREIGN2008-08-29
K923533 — ADMARK1993-03-04
K923461 — PM2002 PROLINE, PM2002 PROLINE EC1992-12-21
K923462 — DELIGHT1992-12-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.