ACRYLIC HERBST SPLINT APPLIANCE

Device, Anti-snoring

SPECIALTY APPLIANCE WORKS, INC.

The following data is part of a premarket notification filed by Specialty Appliance Works, Inc. with the FDA for Acrylic Herbst Splint Appliance.

Pre-market Notification Details

Device IDK083209
510k NumberK083209
Device Name:ACRYLIC HERBST SPLINT APPLIANCE
ClassificationDevice, Anti-snoring
Applicant SPECIALTY APPLIANCE WORKS, INC. 4905 HAMMOND INDUSTRIAL DRIVE Cumming,  GA  30041
ContactCarolyn Thomas
CorrespondentCarolyn Thomas
SPECIALTY APPLIANCE WORKS, INC. 4905 HAMMOND INDUSTRIAL DRIVE Cumming,  GA  30041
Product CodeLRK  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-10-31
Decision Date2009-01-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D85463400TS1 K083209 000
D85463280AS1 K083209 000
D85463280S1 K083209 000
D85463300S1 K083209 000
D85463310S1 K083209 000
D85463312S1 K083209 000
D85463313S1 K083209 000
D85463316AS1 K083209 000
D85463316EAS1 K083209 000
D85463316ES1 K083209 000
D85463316GS1 K083209 000
D85463316S1 K083209 000
D85463320S1 K083209 000
D85463400S1 K083209 000
D85463270S1 K083209 000

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