MULTI ADJUSTABLE FACE MASK

Headgear, Extraoral, Orthodontic

ORTHO TECHNOLOGY

The following data is part of a premarket notification filed by Ortho Technology with the FDA for Multi Adjustable Face Mask.

Pre-market Notification Details

Device IDK000358
510k NumberK000358
Device Name:MULTI ADJUSTABLE FACE MASK
ClassificationHeadgear, Extraoral, Orthodontic
Applicant ORTHO TECHNOLOGY 8909 REGENTS PARB DR., #410 Tampa,  FL  33647
ContactBrian Leaghty
CorrespondentBrian Leaghty
ORTHO TECHNOLOGY 8909 REGENTS PARB DR., #410 Tampa,  FL  33647
Product CodeDZB  
CFR Regulation Number872.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-04
Decision Date2000-06-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00304040018552 K000358 000
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00304040018545 K000358 000
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00190707004866 K000358 000
00190707004859 K000358 000
00190707004842 K000358 000
D828FM220017296 K000358 000

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