OXYGEN, AIR, VACUUM, AND NITROUS COUPLERS

Bracket, Metal, Orthodontic

MEDICAL FITTINGS, INC.

The following data is part of a premarket notification filed by Medical Fittings, Inc. with the FDA for Oxygen, Air, Vacuum, And Nitrous Couplers.

Pre-market Notification Details

Device IDK903214
510k NumberK903214
Device Name:OXYGEN, AIR, VACUUM, AND NITROUS COUPLERS
ClassificationBracket, Metal, Orthodontic
Applicant MEDICAL FITTINGS, INC. 300 HELD DR. Northampton,  PA  18067
ContactJohn R Selady
CorrespondentJohn R Selady
MEDICAL FITTINGS, INC. 300 HELD DR. Northampton,  PA  18067
Product CodeEJF  
CFR Regulation Number872.5410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-07-23
Decision Date1990-09-05

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