DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR

Block, Bite

HUDSON OXYGEN THERAPY SALES CO.

The following data is part of a premarket notification filed by Hudson Oxygen Therapy Sales Co. with the FDA for Disposable Bite Block/tongue Depressor.

Pre-market Notification Details

Device IDK830090
510k NumberK830090
Device Name:DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR
ClassificationBlock, Bite
Applicant HUDSON OXYGEN THERAPY SALES CO. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJXL  
CFR Regulation Number882.5070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-01-11
Decision Date1983-02-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
34026704580225 K830090 000
24026704646542 K830090 000
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