Cleared Traditional

K790843 - SNAP-WAY
(FDA 510(k) Clearance)

May 1979
Decision
29d
Days
Class 2
Risk

K790843 is an FDA 510(k) clearance for the SNAP-WAY. This device is classified as a Headgear, Extraoral, Orthodontic (Class II - Special Controls, product code DZB).

Submitted by Northwest Orthodontics, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 31, 1979, 29 days after receiving the submission on May 2, 1979.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5500.

Submission Details

510(k) Number K790843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1979
Decision Date May 31, 1979
Days to Decision 29 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

Product Code DZB — Headgear, Extraoral, Orthodontic
Device Class Class II - Special Controls
CFR Regulation 21 CFR 872.5500

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