OASYS-ORAL AIRWAY SYSTEM

Device, Anti-snoring

MARK ABRAMSON, D.D.S., INC

The following data is part of a premarket notification filed by Mark Abramson, D.d.s., Inc with the FDA for Oasys-oral Airway System.

Pre-market Notification Details

Device IDK030440
510k NumberK030440
Device Name:OASYS-ORAL AIRWAY SYSTEM
ClassificationDevice, Anti-snoring
Applicant MARK ABRAMSON, D.D.S., INC 35 RENATO COURT Redwood City,  CA  94061
ContactMark Abramson
CorrespondentMark Abramson
MARK ABRAMSON, D.D.S., INC 35 RENATO COURT Redwood City,  CA  94061
Product CodeLRK  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-02-11
Decision Date2003-08-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00810002220029 K030440 000
00810002220081 K030440 000
00810002220074 K030440 000
00810002220067 K030440 000
00810002220050 K030440 000
00810002220043 K030440 000

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