SAFETY STOP NECKSTRAP

Maintainer, Space Preformed, Orthodontic

NORTHWEST ORTHODONTICS, INC.

The following data is part of a premarket notification filed by Northwest Orthodontics, Inc. with the FDA for Safety Stop Neckstrap.

Pre-market Notification Details

Device IDK780814
510k NumberK780814
Device Name:SAFETY STOP NECKSTRAP
ClassificationMaintainer, Space Preformed, Orthodontic
Applicant NORTHWEST ORTHODONTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDYT  
CFR Regulation Number872.5525 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-05-18
Decision Date1978-06-30

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