Cleared Traditional

K790322 - OPTIONAL ACCESSORY FOOT SWITCH MODEL 100
(FDA 510(k) Clearance)

May 1979
Decision
88d
Days
Class 1
Risk

K790322 is an FDA 510(k) clearance for the OPTIONAL ACCESSORY FOOT SWITCH MODEL 100. This device is classified as a Controller, Foot, Handpiece And Cord (Class I - General Controls, product code EBW).

Submitted by Applied Medical Research (Mchenry, US). The FDA issued a Cleared decision on May 14, 1979, 88 days after receiving the submission on February 15, 1979.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K790322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1979
Decision Date May 14, 1979
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

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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