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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name generator, oxygen, portable
510(k) Number K901712
Device Name GUILD MAXOX GENERATOR (MAXOX)
Applicant
GUILD ASSOC., INC.
4089 NORTH LEAP RD.
HILLIARD,  OH  43026
Applicant Contact RICHARD E MORRICAL
Correspondent
GUILD ASSOC., INC.
4089 NORTH LEAP RD.
HILLIARD,  OH  43026
Correspondent Contact RICHARD E MORRICAL
Regulation Number868.5440
Classification Product Code
CAW  
Date Received04/13/1990
Decision Date 02/27/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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