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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Bracket, Metal, Orthodontic
510(k) Number K903214
Device Name OXYGEN, AIR, VACUUM, AND NITROUS COUPLERS
Applicant
Medical Fittings, Inc.
300 Held Dr.
Northampton,  PA  18067
Applicant Contact JOHN R SELADY
Correspondent
Medical Fittings, Inc.
300 Held Dr.
Northampton,  PA  18067
Correspondent Contact JOHN R SELADY
Regulation Number872.5410
Classification Product Code
EJF  
Date Received07/23/1990
Decision Date 09/05/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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