FULL BREATH SLEEP APPLIANCE LOWER (FBSL)

Device, Jaw Repositioning

BRYAN KEROPIAN DDS

The following data is part of a premarket notification filed by Bryan Keropian Dds with the FDA for Full Breath Sleep Appliance Lower (fbsl).

Pre-market Notification Details

Device IDK091035
510k NumberK091035
Device Name:FULL BREATH SLEEP APPLIANCE LOWER (FBSL)
ClassificationDevice, Jaw Repositioning
Applicant BRYAN KEROPIAN DDS 186663 VENTURA BLVD. SUITE 200 Tarzana,  CA  91356
ContactBryan Keropian
CorrespondentBryan Keropian
BRYAN KEROPIAN DDS 186663 VENTURA BLVD. SUITE 200 Tarzana,  CA  91356
Product CodeLQZ  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-10
Decision Date2009-06-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D85460994S1 K091035 000
D85463760AS1 K091035 000
D85463760HLS1 K091035 000
D85463760KS1 K091035 000
D85463760S1 K091035 000
D85463760TES1 K091035 000
D85463760TS1 K091035 000
D85463760VHS1 K091035 000
D85466030S1 K091035 000
D85460994LS1 K091035 000
D85463750S1 K091035 000

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