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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Pressure And Accessories
510(k) Number K901961
Device Name OXYGEN COUPLER, AIR COUPLER & VACUUM COUPLER
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 Number868.5860
Classification Product Code
BYX  
Date Received05/01/1990
Decision Date 08/14/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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