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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Regulator, Pressure, Gas Cylinder
510(k) Number K950777
Device Name OXYGEN REGULATOR
Applicant
Mada Medical Products, Inc.
60 Commerce Rd.
Carlstadt,  NJ  07072
Applicant Contact JEFFREY ADAM
Correspondent
Mada Medical Products, Inc.
60 Commerce Rd.
Carlstadt,  NJ  07072
Correspondent Contact JEFFREY ADAM
Regulation Number868.2700
Classification Product Code
CAN  
Date Received02/21/1995
Decision Date 04/14/1995
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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