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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 K915154
Device Name GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS
Applicant
C.G.H. Medical, Inc.
1185 Oak St.
Lakewood,  CO  80215
Applicant Contact JEFFREY R SHIDEMAN
Correspondent
C.G.H. Medical, Inc.
1185 Oak St.
Lakewood,  CO  80215
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number868.2700
Classification Product Code
CAN  
Date Received11/14/1991
Decision Date 05/27/1992
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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