PM2002 PROLINE, PM2002 PROLINE EC— 510(k) K923461

Name: FDA 510(k) clearance K923461
Creator: U.S. Food and Drug Administration
Published: 1992-12-21

Substantially Equivalent

Planmeca USA, Inc.

FDA 510(k) clearance K923461 for PM2002 PROLINE, PM2002 PROLINE EC, Substantially Equivalent on 1992-12-21. 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: 1992-07-14
Decision date: 1992-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Finland, FI

Download summary PDF View on FDA.gov ↗

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K111361 — PLANMED NUANCE EXCEL2011-09-23
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K923534 — PM2002 PROLINE1994-01-31
K923533 — ADMARK1993-03-04
K923462 — DELIGHT1992-12-21

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