Cleared Traditional

ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115

K014068 · W&H Dentalwerk Buermoos GmbH · Dental
May 2002
Decision
144d
Days
Class 1
Risk

About This 510(k) Submission

K014068 is an FDA 510(k) clearance for the ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115, a Controller, Foot, Handpiece And Cord (Class I — General Controls, product code EBW), submitted by W&H Dentalwerk Buermoos GmbH (Buermoos, AT). The FDA issued a Cleared decision on May 3, 2002, 144 days after receiving the submission on December 10, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K014068 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 2001
Decision Date May 03, 2002
Days to Decision 144 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBW — Controller, Foot, Handpiece And Cord
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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