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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 K883483
Device Name AUTOFLOW PART NUMBER PR3241-420 PRESSURE REGULATOR
Applicant
Autoflow Products, Co.
18442 So. Broadway
Gardena,  CA  90248
Applicant Contact RICHARD HUGHES
Correspondent
Autoflow Products, Co.
18442 So. Broadway
Gardena,  CA  90248
Correspondent Contact RICHARD HUGHES
Regulation Number868.2700
Classification Product Code
CAN  
Date Received08/16/1988
Decision Date 10/07/1988
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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