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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 K813466
Device Name 4004 CONSTANT FLOW REGULATOR
Applicant
Safety Laboratories West
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Safety Laboratories West
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number868.2700
Classification Product Code
CAN  
Date Received12/11/1981
Decision Date 01/07/1982
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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